HEMATASTAT C-70B

Centrifuge, Hematocrit

SEPARATION TECHNOLOGY, INC.

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

Pre-market Notification Details

Device IDK913128
510k NumberK913128
Device Name:HEMATASTAT C-70B
ClassificationCentrifuge, Hematocrit
Applicant SEPARATION TECHNOLOGY, INC. 2340 SOUTH 2700 WEST Salt Lake City,  UT  84119
ContactDale Zabriskie
CorrespondentDale 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 Received1991-05-10
Decision Date1991-09-23

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