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510(k) K913967

DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM by Doxtech, Inc. — Product Code KDW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 18, 1991
Date Received: September 5, 1991
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
Device Class: Class I
Regulation Number: 864.3250
Review Panel: PA
Submission Type