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510(k) K895235

VARIOUS DISPOSABLE SURGICAL GARMENTS by Protect Corp. of Indiana, Inc. — Product Code FYE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 19, 1989
Date Received: August 7, 1989
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Dress, Surgical
Device Class: Class I
Regulation Number: 878.4040
Review Panel: SU
Submission Type