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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 K933023
Device Name CERVICAL TRACTION STRAP
Applicant
Cook (Canada), Inc.
111 Sandiford Dr.
Stouffville, Ontario
L4a 7x5, Canada,  CA
Applicant Contact CARL DICKIE
Correspondent
Cook (Canada), Inc.
111 Sandiford Dr.
Stouffville, Ontario
L4a 7x5, Canada,  CA
Correspondent Contact CARL DICKIE
Regulation Number892.1680
Classification Product Code
KPR  
Date Received06/22/1993
Decision Date 09/20/1993
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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