The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Pediatric Bubble Trap Cat. No. B-100.
| Device ID | K873610 |
| 510k Number | K873610 |
| Device Name: | PEDIATRIC BUBBLE TRAP CAT. NO. B-100 |
| Classification | Catheters, Suction, Tracheobronchial |
| 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 | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-08 |
| Decision Date | 1987-11-05 |