The following data is part of a premarket notification filed by Safetec Of America, Inc. with the FDA for Ez-personal Protection Kit With Spill Clean Up - Plus.
| Device ID | K960048 |
| 510k Number | K960048 |
| Device Name: | EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS |
| Classification | Mask, Surgical |
| Applicant | SAFETEC OF AMERICA, INC. 1055 EAST DELAVAN AVE. Buffalo, NY 14215 |
| Contact | Robert O Dean |
| Correspondent | Robert O Dean SAFETEC OF AMERICA, INC. 1055 EAST DELAVAN AVE. Buffalo, NY 14215 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-04 |
| Decision Date | 1996-07-12 |