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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K944040
Device Name PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM
Applicant
S & S X-Ray Products, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact CAROLANN K COOK
Correspondent
S & S X-Ray Products, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact CAROLANN K COOK
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/18/1994
Decision Date 07/21/1995
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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