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510(k) K874051

INFLATABLE FULL LEG SPLINT by Vinyl Technology, Inc. — Product Code FZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1987
Date Received
October 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Extremity, Inflatable, External
Device Class
Class I
Regulation Number
878.3900
Review Panel
SU
Submission Type

Other clearances by Vinyl Technology, Inc.

  • K874774 — TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS (February 8, 1988)
  • K874053 — INFLATABLE FULL ARM SPLINT (November 23, 1987)
  • K874052 — INFLATABLE HALF LEG SPLINT (November 23, 1987)
  • K874050 — INFLATABLE FOOT & ANKLE SPLINT (November 23, 1987)

Other clearances for product code FZF

  • K881516 — COMPRESAID (April 29, 1988)
  • K874053 — INFLATABLE FULL ARM SPLINT (November 23, 1987)
  • K874052 — INFLATABLE HALF LEG SPLINT (November 23, 1987)
  • K874050 — INFLATABLE FOOT & ANKLE SPLINT (November 23, 1987)
  • K853600 — INFLATABLE AIR SPLINTS (September 19, 1985)
  • K831764 — URIAS PRESSURE SPLINTS, & FIRST AID (September 12, 1983)