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510(k) K922688

EXTRA PROTECTION POLYURETHANE CONDOM by Apex Medical Technologies, Inc. — Product Code MOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1995
Date Received
June 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom, Synthetic
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)
  • K060933 — SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM (May 9, 2006)
  • K954791 — SEMINAL FLUID COLLECTION KIT II (January 5, 1996)
  • K930313 — APEX SPECIMEN BAG (March 18, 1993)
  • K902936 — POLYURETHANE CONDOM (March 6, 1991)
  • K871358 — SENSATIONS BRAND CONDOMS (March 1, 1989)
  • K874539 — HI-TOUCH (TM) BRAND SURGICAL GLOVES (December 14, 1987)

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