The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Anesthesia Face Mask.
| Device ID | K953295 |
| 510k Number | K953295 |
| Device Name: | ANESTHESIA FACE MASK |
| Classification | Mask, Gas, Anesthetic |
| Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Robert A Virag |
| Correspondent | Robert A Virag MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-14 |
| Decision Date | 1995-08-11 |