The following data is part of a premarket notification filed by Gam Industries, Inc. with the FDA for Combo Mask.
| Device ID | K941336 |
| 510k Number | K941336 |
| Device Name: | COMBO MASK |
| Classification | Mask, Oxygen, Non-rebreathing |
| Applicant | GAM INDUSTRIES, INC. P.O. BOX 2226 Petersburg, VA 23804 -1526 |
| Contact | Gary J Beden |
| Correspondent | Gary J Beden GAM INDUSTRIES, INC. P.O. BOX 2226 Petersburg, VA 23804 -1526 |
| Product Code | KGB |
| CFR Regulation Number | 868.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-21 |
| Decision Date | 1994-09-09 |