The following data is part of a premarket notification filed by Genzyme Surgical Product (genzyme Biosurgery) with the FDA for Rapid Transfer Blood Bag Model A-1650, Rapid Transfer Blood Bag Model S-250.
| Device ID | K982712 |
| 510k Number | K982712 |
| Device Name: | RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 |
| Classification | Apparatus, Autotransfusion |
| Applicant | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Contact | Stephen M Page |
| Correspondent | Stephen M Page GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River, MA 02720 -4740 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-04 |
| Decision Date | 1998-12-18 |
| Summary: | summary |