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510(k) K954556

SURGICAL CAP by Thai Disposable Products Co., Ltd. — Product Code FYF

K954556 is an FDA 510(k) premarket notification submitted by Thai Disposable Products Co., Ltd. for the device "SURGICAL CAP". The FDA issued a decision of Substantially Equivalent on March 12, 1996. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1996
Date Received
October 2, 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 for product code FYF

  • K972227 — SHOE COVER (September 9, 1997)
  • K955833 — NIOMED SURGICAL CAPS (March 15, 1996)
  • K954454 — NIOMED SURGICAL HOOD (January 23, 1996)
  • K954455 — NIOMED BOUFFANT CAPS (January 23, 1996)
  • K953878 — BOUFFANT CAP (January 5, 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)
  • K882283 — BOUFFANT CAP (June 23, 1988)
  • K882284 — SURGEONS CAP (June 23, 1988)

FDA data resources