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510(k) K936087

CARPAL BOX by Innovative Medical Technologies, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1994
Date Received
December 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K904237 — RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM (May 9, 1991)
  • K854194 — IMT ULTRASONIC STRIDE MONITOR (May 2, 1986)

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