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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K822340
Device Name EXTRACORPOREAL SINGLE NEEDLE MODULE
Applicant
Extracorporeal Medical Specialities, Inc.
Royal & Ross Rd.S
King Of Prussia,  PA  19406
Applicant Contact JAMES J MCDCRACKEN
Correspondent
Extracorporeal Medical Specialities, Inc.
Royal & Ross Rd.S
King Of Prussia,  PA  19406
Correspondent Contact JAMES J MCDCRACKEN
Regulation Number876.5820
Classification Product Code
KOC  
Date Received08/04/1982
Decision Date 11/03/1982
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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