The following data is part of a premarket notification filed by Certified Safety Mfg., Inc. with the FDA for Bloodborne Pathogen Kit.
| Device ID | K953102 |
| 510k Number | K953102 |
| Device Name: | BLOODBORNE PATHOGEN KIT |
| Classification | Mask, Surgical |
| Applicant | CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Contact | Howard Gerson |
| Correspondent | Howard Gerson CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1995-12-11 |