The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Ajdjustable Suction Control Valve.
Device ID | K851406 |
510k Number | K851406 |
Device Name: | AJDJUSTABLE SUCTION CONTROL VALVE |
Classification | Suction Control, Intracardiac, Cardiopulmonary Bypass |
Applicant | AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa, CA 92626 |
Contact | George G Siposs |
Correspondent | George G Siposs AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa, CA 92626 |
Product Code | DWD |
CFR Regulation Number | 870.4430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-09 |
Decision Date | 1985-08-05 |