The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Air-soft-disposable, Anesthesisa/respiratory Face Mask.
| Device ID | K951043 |
| 510k Number | K951043 |
| Device Name: | AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK |
| Classification | Mask, Gas, Anesthetic |
| Applicant | PROMEDIC, INC. 10415 BRIGGS COURT Indianapolis, IN 46256 -9719 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden PROMEDIC, INC. 10415 BRIGGS COURT 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 | 1995-03-07 |
| Decision Date | 1995-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44710810088696 | K951043 | 000 |