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510(k) K945246

PREVENTOR AND PROTECTOR LATEX CONDOMS by American Pharmaceutical Co., Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1995
Date Received
October 27, 1994
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

Other clearances by American Pharmaceutical Co., Inc.

  • K812567 — RELIEF (November 10, 1981)

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