K962821 is an FDA 510(k) clearance for the EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT. This device is classified as a Anesthesia Conduction Kit (Class II - Special Controls, product code CAZ).
Submitted by Global Medical Products, Ltd. (Woodbury, US). The FDA issued a Cleared decision on November 13, 1996, 117 days after receiving the submission on July 19, 1996.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5140. This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance..
| 510(k) Number | K962821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | July 19, 1996 |
| Decision Date | November 13, 1996 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CAZ — Anesthesia Conduction Kit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5140 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance. |