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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 K950061
Device Name HERCULES RADIATION THERAPY COUCH
Applicant
Precision Therapy Intl., Inc.
2999 NE 191 St.
North Miami Beach,  FL  33180
Applicant Contact CAROL L PATTERSON
Correspondent
Precision Therapy Intl., Inc.
2999 NE 191 St.
North Miami Beach,  FL  33180
Correspondent Contact CAROL L PATTERSON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/06/1995
Decision Date 08/16/1995
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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