HEMATASTAT H-70

Centrifuge, Hematocrit

SEPARATION TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Separation Technology, Inc. with the FDA for Hematastat H-70.

Pre-market Notification Details

Device IDK890849
510k NumberK890849
Device Name:HEMATASTAT H-70
ClassificationCentrifuge, Hematocrit
Applicant SEPARATION TECHNOLOGY, INC. 2340 SOUTH 2700 WEST Salt Lake City,  UT  84119
ContactKenneth L Zabriskie
CorrespondentKenneth L Zabriskie
SEPARATION TECHNOLOGY, INC. 2340 SOUTH 2700 WEST Salt Lake City,  UT  84119
Product CodeGKG  
CFR Regulation Number864.6400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-21
Decision Date1989-03-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.