K972302 is an FDA 510(k) clearance for the POCKET COUNT OR SAFETCOUNT. This device is classified as a Counter, Sponge, Surgical (Class I - General Controls, product code LWH).
Submitted by Sage Products, Inc. (Crystal Lake, US). The FDA issued a Cleared decision on July 25, 1997, 36 days after receiving the submission on June 19, 1997.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.2740.
| 510(k) Number | K972302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1997 |
| Decision Date | July 25, 1997 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LWH — Counter, Sponge, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.2740 |