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510(k) K903715

CONDOM SEAL by Mark Sullivan, M.D., P.C. — Product Code EXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1991
Date Received
August 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Incontinence, Urosheath Type, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

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