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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 K914066
Device Name ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS
Applicant
Laparomed Corp.
9272 Jeronimo Rd., Unit 109
Irvine,  CA  92718
Applicant Contact PAUL LUBOCK
Correspondent
Laparomed Corp.
9272 Jeronimo Rd., Unit 109
Irvine,  CA  92718
Correspondent Contact PAUL LUBOCK
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/11/1991
Decision Date 11/07/1991
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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