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510(k) K895092

KUT-SHIELD by Kut-Guard, Inc. — Product Code FYH

K895092 is an FDA 510(k) premarket notification submitted by Kut-Guard, Inc. for the device "KUT-SHIELD". The FDA issued a decision of Substantially Equivalent on September 26, 1989. The device falls under product code FYH (Splint, Extremity, Noninflatable, External, Sterile), a Class I device regulated under 21 CFR 878.3910. Kut-Guard, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1989
Date Received
August 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Extremity, Noninflatable, External, Sterile
Device Class
Class I
Regulation Number
878.3910
Review Panel
HO
Submission Type

Other clearances by Kut-Guard, Inc.

  • K895884 — BANDAGE REMOVAL STRIP (December 27, 1989)

Other clearances for product code FYH

  • K925145 — TRACE MODEL #'S 840, 841, 842, 845 (May 19, 1993)
  • K924984 — SPECIALIST(R) WALKER (February 1, 1993)
  • K852558 — SPLINTS(ALL TYPE) (July 2, 1985)
  • K843400 — HYDRO-SPLINT A SPONGE-COMPRESS DRESS (October 24, 1984)
  • K821693 — J & J DIP WATER ADDITIVE (July 2, 1982)
  • K802522 — DELTA-LITE CASTING TAPE & SPLINTS (January 8, 1981)
  • K801436 — ORTHOPEDIC LOWER EXTREMITY SUSPENSION (June 26, 1980)

FDA data resources