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510(k) K853600

INFLATABLE AIR SPLINTS by Hospitak, Inc. — Product Code FZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1985
Date Received
August 27, 1985
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

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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)
  • K874051 — INFLATABLE FULL LEG SPLINT (November 23, 1987)
  • K874050 — INFLATABLE FOOT & ANKLE SPLINT (November 23, 1987)
  • K831764 — URIAS PRESSURE SPLINTS, & FIRST AID (September 12, 1983)