The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Hepchek (tm) Heparin Absorption Filter.
| Device ID | K884534 |
| 510k Number | K884534 |
| Device Name: | PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Contact | Samuel T Wortham |
| Correspondent | Samuel T Wortham PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-28 |
| Decision Date | 1989-01-24 |