The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Closed Paracentesis System W/boasberg Catheter Set.
| Device ID | K870704 |
| 510k Number | K870704 |
| Device Name: | CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET |
| Classification | Catheter, Irrigation |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Contact | Lawrence W Getlin |
| Correspondent | Lawrence W Getlin AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-20 |
| Decision Date | 1987-03-27 |