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510(k) K925145

TRACE MODEL #'S 840, 841, 842, 845 by Trace Medical Equipment, Inc. — Product Code FYH

K925145 is an FDA 510(k) premarket notification submitted by Trace Medical Equipment, Inc. for the device "TRACE MODEL #'S 840, 841, 842, 845". The FDA issued a decision of Substantially Equivalent on May 19, 1993. The device falls under product code FYH (Splint, Extremity, Noninflatable, External, Sterile), a Class I device regulated under 21 CFR 878.3910. Trace Medical Equipment, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1993
Date Received
October 13, 1992
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 Trace Medical Equipment, Inc.

  • K925502 — TRACE MODEL# 840, 841,842 & 845 ARM BOARD (January 12, 1993)

Other clearances for product code FYH

  • K924984 — SPECIALIST(R) WALKER (February 1, 1993)
  • K895092 — KUT-SHIELD (September 26, 1989)
  • 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