The following data is part of a premarket notification filed by Pharma Systems, Inc. with the FDA for Bacttrap.
| Device ID | K903056 |
| 510k Number | K903056 |
| Device Name: | BACTTRAP |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | PHARMA SYSTEMS, INC. 32 OAK PLACE Bernardsville, NJ 07924 |
| Contact | Hal Norris |
| Correspondent | Hal Norris PHARMA SYSTEMS, INC. 32 OAK PLACE Bernardsville, NJ 07924 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1990-11-05 |