K953102 is an FDA 510(k) clearance for the BLOODBORNE PATHOGEN KIT. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on December 11, 1995, 161 days after receiving the submission on July 3, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K953102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1995 |
| Decision Date | December 11, 1995 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |