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510(k) K843400

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

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)