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 |