The following data is part of a premarket notification filed by Bentec Medical, Inc. with the FDA for Disposable Silicone Epistaxis Catheter V-27030/disposable Silicone Epistaxis Catheter Kit V-27030k.
| Device ID | K971411 |
| 510k Number | K971411 |
| Device Name: | DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K |
| Classification | Balloon, Epistaxis |
| Applicant | BENTEC MEDICAL, INC. 4234 NORTH FREEWAY BLVD. Sacramento, CA 95834 |
| Contact | Lou Matson |
| Correspondent | Lou Matson BENTEC MEDICAL, INC. 4234 NORTH FREEWAY BLVD. Sacramento, CA 95834 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-16 |
| Decision Date | 1997-06-03 |