The following data is part of a premarket notification filed by Separation Technology, Inc. with the FDA for Hematastat H-70.
Device ID | K890849 |
510k Number | K890849 |
Device Name: | HEMATASTAT H-70 |
Classification | Centrifuge, Hematocrit |
Applicant | SEPARATION TECHNOLOGY, INC. 2340 SOUTH 2700 WEST Salt Lake City, UT 84119 |
Contact | Kenneth L Zabriskie |
Correspondent | Kenneth L 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 | 1989-02-21 |
Decision Date | 1989-03-21 |