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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K936087
Device Name CARPAL BOX
Applicant
Innovative Medical Technologies, Inc.
2629 Durant Oaks Dr.
Valrico,  FL  33594
Applicant Contact STEVE W CLAPP
Correspondent
Innovative Medical Technologies, Inc.
2629 Durant Oaks Dr.
Valrico,  FL  33594
Correspondent Contact STEVE W CLAPP
Regulation Number892.1680
Classification Product Code
KPR  
Date Received12/21/1993
Decision Date 10/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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