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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 K895697
Device Name VAC FIX(R) SYSTEM
Applicant
S&S Par Scientific
55 Northern Blvd.
Suite 205
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
S&S Par Scientific
55 Northern Blvd.
Suite 205
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/21/1989
Decision Date 01/12/1990
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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