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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 K930506
Device Name THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM
Applicant
Pinecliff Assoc.
217 Chimmey Ln.
Wilmington,  NC  28409
Applicant Contact SAYLOR
Correspondent
Pinecliff Assoc.
217 Chimmey Ln.
Wilmington,  NC  28409
Correspondent Contact SAYLOR
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/01/1993
Decision Date 08/29/1994
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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