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510(k) K852558

SPLINTS(ALL TYPE) by The Huxley Instrument Corp. — Product Code FYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1985
Date Received
June 17, 1985
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 The Huxley Instrument Corp.

  • K852721 — BOZEMAN UTERINE FORCEPS, STRAIGHT, 10+410 0R 420 (September 6, 1985)
  • K853016 — STILLE ANGULAR RONGEUR, 8-3/4 SS 410 (August 7, 1985)
  • K852993 — BONE RONGEURS (August 7, 1985)
  • K853015 — SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420 (July 29, 1985)
  • K852716 — TAYLOR PERCUSSION HAMMER SS 410 OR 420 (July 26, 1985)
  • K852717 — IRIS FORCEPS, DELICATE, 1X2 TEETH, STRAIGHT, 4XSS (July 15, 1985)
  • K852719 — MAYO HEGAR NEEDLE HOLDER, G+SS 410 OR 420 (July 15, 1985)
  • K852731 — LISTER BANDAGE SCISSORS, 5-1/2+SS 410 OR 420 (July 15, 1985)
  • K852732 — IRIS SCISSORS, CURVED, 4-1/2+SS 410 OR 420 (July 15, 1985)
  • K852723 — FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 (July 15, 1985)

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)
  • 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)