The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Bubble Trap-filter Cat. No B180f37.
Device ID | K873316 |
510k Number | K873316 |
Device Name: | BUBBLE TRAP-FILTER CAT. NO B180F37 |
Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
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 | DTM |
CFR Regulation Number | 870.4260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-19 |
Decision Date | 1988-07-14 |