The following data is part of a premarket notification filed by Biomedical Development Co. with the FDA for Nuvo Barrier Film.
| Device ID | K980117 |
| 510k Number | K980117 |
| Device Name: | NUVO BARRIER FILM |
| Classification | Bandage, Liquid |
| Applicant | BIOMEDICAL DEVELOPMENT CO. 6401 MEADOWS WEST DR. Fort Worth, TX 76132 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer BIOMEDICAL DEVELOPMENT CO. 6401 MEADOWS WEST DR. Fort Worth, TX 76132 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-13 |
| Decision Date | 1998-12-18 |
| Summary: | summary |