The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Gas Line Guardian Filter.
| Device ID | K850327 |
| 510k Number | K850327 |
| Device Name: | PALL GAS LINE GUARDIAN FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Contact | Sidney Krakauer |
| Correspondent | Sidney Krakauer PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-02-26 |