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510(k) K910105

PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 by International Technidyne Corp. — Product Code GFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1991
Date Received
January 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protamine Sulphate
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

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