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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 K994428
Device Name E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE
Applicant
Valleylab, Inc.
5920 Longbow Dr.
P.O. Box 9015
Boulder,  CO  80301
Applicant Contact ROBERT C MOORE JR
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
P.O. Box 9015
Boulder,  CO  80301
Correspondent Contact ROBERT C MOORE JR
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/30/1999
Decision Date 03/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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