The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Pharmaseal Medi-vac Intra-oper. Autotransfus. Kit.
| Device ID | K861677 |
| 510k Number | K861677 |
| Device Name: | PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT |
| Classification | Apparatus, Autotransfusion |
| 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 | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-01 |
| Decision Date | 1986-06-16 |