The following data is part of a premarket notification filed by Fvtnks with the FDA for Disposable, Anesthesia/respiratory Face Mask.
| Device ID | K945440 |
| 510k Number | K945440 |
| Device Name: | DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK |
| Classification | Mask, Gas, Anesthetic |
| Applicant | FVTNKS 10415 BRIGGS CT. Indianapolis, IN 46256 -9719 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden FVTNKS 10415 BRIGGS CT. Indianapolis, IN 46256 -9719 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-07 |
| Decision Date | 1994-11-08 |