The following data is part of a premarket notification filed by Separation Technology, Inc. with the FDA for Hematastat C-70b.
| Device ID | K913128 |
| 510k Number | K913128 |
| Device Name: | HEMATASTAT C-70B |
| Classification | Centrifuge, Hematocrit |
| Applicant | SEPARATION TECHNOLOGY, INC. 2340 SOUTH 2700 WEST Salt Lake City, UT 84119 |
| Contact | Dale Zabriskie |
| Correspondent | Dale Zabriskie SEPARATION TECHNOLOGY, INC. 2340 SOUTH 2700 WEST Salt Lake City, UT 84119 |
| Product Code | GKG |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-10 |
| Decision Date | 1991-09-23 |