K913306 is an FDA 510(k) clearance for the BONE-TEMNO/STERNUM-TEMNO. This device is classified as a Bone Marrow Collection/transfusion Kit (Class II - Special Controls, product code LWE).
Submitted by Proact, Ltd. (State College, US). The FDA issued a Cleared decision on November 1, 1991, 99 days after receiving the submission on July 25, 1991.
This device falls under the General Hospital FDA review panel. 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 | K913306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1991 |
| Decision Date | November 01, 1991 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LWE — Bone Marrow Collection/transfusion Kit |
| Device Class | Class II - Special Controls |
| 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. |