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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K900629
Device Name BERNSCO LUER NEEDLER ADAPTOR
Applicant
Bernsco Surgical Supply, Inc.
6653 NE Windermere Rd.
Seattle,  WA  98115
Applicant Contact BERNSTEIN, MD
Correspondent
Bernsco Surgical Supply, Inc.
6653 NE Windermere Rd.
Seattle,  WA  98115
Correspondent Contact BERNSTEIN, MD
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/08/1990
Decision Date 03/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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