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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K896307
Device Name INSULATION PAD
Applicant
Bio-Vascular, Inc.
2670 Patton Rd.
St. Paul,  MN  55113
Applicant Contact SHERRY KRATTLEY
Correspondent
Bio-Vascular, Inc.
2670 Patton Rd.
St. Paul,  MN  55113
Correspondent Contact SHERRY KRATTLEY
Regulation Number870.4500
Classification Product Code
DWS  
Date Received10/31/1989
Decision Date 01/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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