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510(k) K880185

DUET (CONDOMS) by American Laboratories, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1988
Date Received
January 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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