The following data is part of a premarket notification filed by Medical Fittings, Inc. with the FDA for Oxygen, Air, Vacuum, And Nitrous Couplers.
| Device ID | K903214 |
| 510k Number | K903214 |
| Device Name: | OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | MEDICAL FITTINGS, INC. 300 HELD DR. Northampton, PA 18067 |
| Contact | John R Selady |
| Correspondent | John R Selady MEDICAL FITTINGS, INC. 300 HELD DR. Northampton, PA 18067 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-23 |
| Decision Date | 1990-09-05 |