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510(k) K802522

DELTA-LITE CASTING TAPE & SPLINTS by Johnson & Johnson Professionals, Inc. — Product Code FYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1981
Date Received
October 15, 1980
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

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  • K983141 — CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS (November 6, 1998)
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  • K980778 — HAKIM MICRO PROGRAMMABLE VALVE SYSTEM (July 17, 1998)
  • K974739 — HAKIM PROGRAMMABLE VALVE SYSTEM (July 1, 1998)
  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)

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)
  • K843400 — HYDRO-SPLINT A SPONGE-COMPRESS DRESS (October 24, 1984)
  • K821693 — J & J DIP WATER ADDITIVE (July 2, 1982)
  • K801436 — ORTHOPEDIC LOWER EXTREMITY SUSPENSION (June 26, 1980)