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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, for peritoneal dialysis, disposable
510(k) Number K812130
Device Name SPIKE GUARD
Applicant
CLINIPAD CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CLINIPAD CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received07/27/1981
Decision Date 09/09/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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