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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 K021124
Device Name ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
Applicant
Wfr/Aquaplast Corp.
30 Lawlins Park
Wyckoff,  NJ  07481
Applicant Contact J DAMON KIRK
Correspondent
Wfr/Aquaplast Corp.
30 Lawlins Park
Wyckoff,  NJ  07481
Correspondent Contact J DAMON KIRK
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/08/2002
Decision Date 07/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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