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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Peritoneal Dialysate
510(k) Number K933619
Device Name PD-PAK
Applicant
GENERAL MEDICAL MFG. CO.
8741 LANDMARK RD.
RICHMOND,  VA  23228
Applicant Contact ALFRED H GREBE
Correspondent
GENERAL MEDICAL MFG. CO.
8741 LANDMARK RD.
RICHMOND,  VA  23228
Correspondent Contact ALFRED H GREBE
Regulation Number876.5630
Classification Product Code
MLW  
Date Received07/19/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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