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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 K935067
Device Name AQUAPLAST
Applicant
Wfr/Aquaplast Corp.
P.O. Box 635
Wyckoff,  NJ  07481
Applicant Contact JOHN R KIRK
Correspondent
Wfr/Aquaplast Corp.
P.O. Box 635
Wyckoff,  NJ  07481
Correspondent Contact JOHN R KIRK
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/20/1993
Decision Date 05/26/1994
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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