The following data is part of a premarket notification filed by Brennen Medical, Inc. with the FDA for Brennen Medical Sterile Saline Solution.
| Device ID | K935060 |
| 510k Number | K935060 |
| Device Name: | BRENNEN MEDICAL STERILE SALINE SOLUTION |
| Classification | Bandage, Liquid |
| Applicant | BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Jeffrey M Williams |
| Correspondent | Jeffrey M Williams BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-20 |
| Decision Date | 1994-01-10 |