The following data is part of a premarket notification filed by American Custom Medical, Inc. with the FDA for Fluorofilm(r).
| Device ID | K933800 |
| 510k Number | K933800 |
| Device Name: | FLUOROFILM(R) |
| Classification | Balloon, Epistaxis |
| Applicant | AMERICAN CUSTOM MEDICAL, INC. 3403 73RD ST. Lubbock, TX 79413 |
| Contact | Bruce G Ruefer |
| Correspondent | Bruce G Ruefer AMERICAN CUSTOM MEDICAL, INC. 3403 73RD ST. Lubbock, TX 79413 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-04 |
| Decision Date | 1994-06-24 |