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510(k) K843400

HYDRO-SPLINT A SPONGE-COMPRESS DRESS by Compression Splint Products, Inc. — Product Code FYH

K843400 is an FDA 510(k) premarket notification submitted by Compression Splint Products, Inc. for the device "HYDRO-SPLINT A SPONGE-COMPRESS DRESS". The FDA issued a decision of Substantially Equivalent on October 24, 1984. The device falls under product code FYH (Splint, Extremity, Noninflatable, External, Sterile), a Class I device regulated under 21 CFR 878.3910.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1984
Date Received
August 30, 1984
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 for product code FYH

  • K925145 — TRACE MODEL #'S 840, 841, 842, 845 (May 19, 1993)
  • K924984 — SPECIALIST(R) WALKER (February 1, 1993)
  • K895092 — KUT-SHIELD (September 26, 1989)
  • K852558 — SPLINTS(ALL TYPE) (July 2, 1985)
  • 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