The following data is part of a premarket notification filed by Eastmed Enterprises Inc. with the FDA for Mask, Gas, Anesthetic.
| Device ID | K882434 |
| 510k Number | K882434 |
| Device Name: | MASK, GAS, ANESTHETIC |
| Classification | Mask, Gas, Anesthetic |
| Applicant | EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton, NJ 08053 |
| Contact | Supti Putatunda |
| Correspondent | Supti Putatunda EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton, NJ 08053 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-14 |
| Decision Date | 1988-06-30 |