The following data is part of a premarket notification filed by Medical Fittings, Inc. with the FDA for Schrader Oxygen/air Vac&nitr-oxide Male Quick Conn.
Device ID | K905094 |
510k Number | K905094 |
Device Name: | SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN |
Classification | Tubing, Pressure And Accessories |
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 | BYX |
CFR Regulation Number | 868.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-13 |
Decision Date | 1990-11-20 |