The following data is part of a premarket notification filed by Meridian Medical Systems, Inc. with the FDA for Disposable, Preformed Face Mask.
| Device ID | K944157 |
| 510k Number | K944157 |
| Device Name: | DISPOSABLE, PREFORMED FACE MASK |
| Classification | Mask, Gas, Anesthetic |
| Applicant | MERIDIAN MEDICAL SYSTEMS, INC. 8102 WOOD LAND DR. Indianapolis, IN 46278 |
| Contact | Robert Richmond |
| Correspondent | Robert Richmond MERIDIAN MEDICAL SYSTEMS, INC. 8102 WOOD LAND DR. Indianapolis, IN 46278 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-26 |
| Decision Date | 1994-10-03 |