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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Mount, X-Ray, Diagnostic
510(k) Number K843928
Device Name COUNTERBALANCED VERTICAL CASSETTE HOLDER
Applicant
Poersch Metal Mfg. Co.
4027-31 W. Kinzie St.
Chicago,  IL  60624
Applicant Contact TUCCI
Correspondent
Poersch Metal Mfg. Co.
4027-31 W. Kinzie St.
Chicago,  IL  60624
Correspondent Contact TUCCI
Regulation Number892.1770
Classification Product Code
IYB  
Date Received10/05/1984
Decision Date 12/17/1984
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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