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510(k) K953878

BOUFFANT CAP by American Threshold Industries, Inc. — Product Code FYF

K953878 is an FDA 510(k) premarket notification submitted by American Threshold Industries, Inc. for the device "BOUFFANT CAP". The FDA issued a decision of Substantially Equivalent on January 5, 1996. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. American Threshold Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1996
Date Received
August 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Surgical
Device Class
Class I
Regulation Number
878.4040
Review Panel
SU
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)
  • 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)
  • K912110 — DISPOSABLE O.R. TOWEL (July 25, 1991)
  • K894383 — DISPOSABLE SHOE COVER (September 12, 1989)

Other clearances for product code FYF

  • K972227 — SHOE COVER (September 9, 1997)
  • K955833 — NIOMED SURGICAL CAPS (March 15, 1996)
  • K954556 — SURGICAL CAP (March 12, 1996)
  • K954454 — NIOMED SURGICAL HOOD (January 23, 1996)
  • K954455 — NIOMED BOUFFANT CAPS (January 23, 1996)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K913700 — DISPOSABLE BOUFFANT CAP (October 4, 1991)
  • K882346 — INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD (June 30, 1988)
  • K882284 — SURGEONS CAP (June 23, 1988)
  • K882283 — BOUFFANT CAP (June 23, 1988)

FDA data resources