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510(k) K874410

CUMEVAC by Cumes-Honikman Partnership — Product Code FFD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 3, 1987
Date Received: October 28, 1987
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Evacuator, Bladder, Manually Operated
Device Class: Class I
Regulation Number: 876.4370
Review Panel: GU
Submission Type