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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Transducer, Dialysis
510(k) Number K812107
Device Name RENALAB TRANSDUCER PROTECTOR, .22 MICRON
Applicant
RENALAB
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
RENALAB
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
FIB  
Date Received07/27/1981
Decision Date 08/20/1981
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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