The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for American Twa Way Filter -bacterial/viral-retentive.
| Device ID | K850265 |
| 510k Number | K850265 |
| Device Name: | AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 1015 GRANDVIEW P.O. BOX 1300 Glendale, CA 91209 |
| Contact | Lawrence W Gettlin |
| Correspondent | Lawrence W Gettlin AMERICAN PHARMASEAL DIV. AHSC 1015 GRANDVIEW P.O. BOX 1300 Glendale, CA 91209 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-23 |
| Decision Date | 1985-04-05 |