The following data is part of a premarket notification filed by Inhal-o-tech Medical Plastic with the FDA for Mask, Disposable Oxygen Therapy.
| Device ID | K760329 |
| 510k Number | K760329 |
| Device Name: | MASK, DISPOSABLE OXYGEN THERAPY |
| Classification | Mask, Oxygen |
| Applicant | INHAL-O-TECH MEDICAL PLASTIC P.O. Box 385 Blue Spring, MO 64015 |
| Contact | Joseph W Brown |
| Correspondent | Joseph W Brown INHAL-O-TECH MEDICAL PLASTIC P.O. Box 385 Blue Springs, MO 64015 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-28 |
| Decision Date | 1976-09-30 |