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510(k) K953583

LUBRICATED CONDOM by Tactyl Technologies, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1996
Date Received
August 1, 1995
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 Tactyl Technologies, Inc.

  • K955464 — TACTYLON POWDER FREE EXAMINATION GLOVE (April 25, 1996)
  • K955419 — POWDER FREE TACTYLON SURGEONS GLOVE (April 15, 1996)
  • K950185 — TACTYLON(TM) POWDER FREE SURGEONS GLOVE (April 13, 1995)
  • K911431 — TACTYLON(TM) CONDOM (December 27, 1994)
  • K905109 — PATIENT EXAMINATION GLOVE/HYPOALLERGENIC (November 21, 1990)
  • K902831 — TACTYLON TM SURGICAL GLOVE (July 10, 1990)

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