The following data is part of a premarket notification filed by Transfusion Technologies Corp. with the FDA for Orthopedic Perioperative Autotransfusion (orthopat) System.
| Device ID | K982660 |
| 510k Number | K982660 |
| Device Name: | ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | TRANSFUSION TECHNOLOGIES CORP. 9 ERIE DR. Natick, MA 01760 |
| Contact | John J Sokolowski |
| Correspondent | John J Sokolowski TRANSFUSION TECHNOLOGIES CORP. 9 ERIE DR. Natick, MA 01760 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-30 |
| Decision Date | 1999-03-30 |
| Summary: | summary |