K960210 is an FDA 510(k) clearance for the CPR ORTHO HAND PACK. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on April 12, 1996, 87 days after receiving the submission on January 16, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K960210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1996 |
| Decision Date | April 12, 1996 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRG — Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |