The following data is part of a premarket notification filed by American Gage & Medical, Inc. with the FDA for Yoke Assembly Medical Gas.
Device ID | K935283 |
510k Number | K935283 |
Device Name: | YOKE ASSEMBLY MEDICAL GAS |
Classification | Yoke Assembly, Medical Gas |
Applicant | AMERICAN GAGE & MEDICAL, INC. P.O. BOX 15368 San Francisco, CA 94115 |
Contact | S K Choudhary |
Correspondent | S K Choudhary AMERICAN GAGE & MEDICAL, INC. P.O. BOX 15368 San Francisco, CA 94115 |
Product Code | CAM |
CFR Regulation Number | 868.6885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-11-03 |
Decision Date | 1994-03-11 |