The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Pressure Barrier Kit Cat. No. Pbk-3.
Device ID | K873802 |
510k Number | K873802 |
Device Name: | PRESSURE BARRIER KIT CAT. NO. PBK-3 |
Classification | Gauge, Pressure, Coronary, 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 | DXS |
CFR Regulation Number | 870.4310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-18 |
Decision Date | 1987-11-06 |