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510(k) K871358

SENSATIONS BRAND CONDOMS by Apex Medical Technologies, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1989
Date Received
April 6, 1987
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 Apex Medical Technologies, Inc.

  • K112165 — RHEA CUP (May 24, 2012)
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  • K954791 — SEMINAL FLUID COLLECTION KIT II (January 5, 1996)
  • K922688 — EXTRA PROTECTION POLYURETHANE CONDOM (May 4, 1995)
  • K930313 — APEX SPECIMEN BAG (March 18, 1993)
  • K902936 — POLYURETHANE CONDOM (March 6, 1991)
  • K874539 — HI-TOUCH (TM) BRAND SURGICAL GLOVES (December 14, 1987)

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