The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for American Pharmaseal Triple Lumen Catheter.
| Device ID | K852491 |
| 510k Number | K852491 |
| Device Name: | AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 1015 GRANDVIEW P.O. BOX 1300 Glendale, CA 91209 |
| Contact | Lawrence W Getlin |
| Correspondent | Lawrence W Getlin AMERICAN PHARMASEAL DIV. AHSC 1015 GRANDVIEW P.O. BOX 1300 Glendale, CA 91209 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-12 |
| Decision Date | 1985-09-25 |