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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K913896
Device Name JAIN BLOOD SHIELD
Applicant
Jain Surgical Equipment, Inc.
7829 Sprinkle Rd.
Kalamazoo,  MI  49001
Applicant Contact MELISA M ROOT
Correspondent
Jain Surgical Equipment, Inc.
7829 Sprinkle Rd.
Kalamazoo,  MI  49001
Correspondent Contact MELISA M ROOT
Regulation Number880.6740
Classification Product Code
JOL  
Date Received08/30/1991
Decision Date 03/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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