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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 K895500
Device Name PATIENT POSITIONING ACCESSORIES
Applicant
Perkins Mfg. Co.
1510 N.Washington Ave.
Dallas,  TX  75204
Applicant Contact JAMES C FURSE
Correspondent
Perkins Mfg. Co.
1510 N.Washington Ave.
Dallas,  TX  75204
Correspondent Contact JAMES C FURSE
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/12/1989
Decision Date 11/06/1989
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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