The following data is part of a premarket notification filed by North Safety Products with the FDA for North Bloodborne Pathogen Response Kit.
| Device ID | K950554 |
| 510k Number | K950554 |
| Device Name: | NORTH BLOODBORNE PATHOGEN RESPONSE KIT |
| Classification | Mask, Surgical |
| Applicant | NORTH SAFETY PRODUCTS 1515 ELMWOOD RD. Rockford, IL 61103 |
| Contact | James Wright |
| Correspondent | James Wright NORTH SAFETY PRODUCTS 1515 ELMWOOD RD. Rockford, IL 61103 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-03 |
| Decision Date | 1995-06-28 |