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510(k) K912110

DISPOSABLE O.R. TOWEL by American Threshold Industries, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1991
Date Received
May 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by American Threshold Industries, Inc.

  • K971483 — SECURE-WRAP (TM) STERILIZATION WRAP (June 24, 1997)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K953878 — BOUFFANT CAP (January 5, 1996)
  • K952115 — BARRIER GOWN, KOOL-GARD BACKLESS GOWN (September 25, 1995)
  • K952114 — KOOL GARD SINGLES GOWN (September 25, 1995)
  • K952116 — COVER GOWN (September 5, 1995)
  • K934085 — MODIFICATION OF SURGICAL EYESHIELD MASK (November 12, 1993)
  • K915530 — NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (August 17, 1992)
  • K915740 — DISPOSABLE O.R. TOWEL, STERILE (June 22, 1992)
  • K894383 — DISPOSABLE SHOE COVER (September 12, 1989)

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