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510(k) K992081

VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL by Suretex Prophylactics (India) , Ltd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1999
Date Received
June 21, 1999
Clearance Type
Abbreviated
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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