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510(k) K913058

REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 by Helena Laboratories — Product Code CEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1991
Date Received
July 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoretic, Protein Fractionation
Device Class
Class I
Regulation Number
862.1630
Review Panel
CH
Submission Type

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