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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 K913281
Device Name E-Z CLEAN LAPAROSCOPIC ELECTRODE
Applicant
Megadyne Medical Products, Inc.
6202 Stratler St.
Murray,  UT  84107
Applicant Contact DREW D WEAVER
Correspondent
Megadyne Medical Products, Inc.
6202 Stratler St.
Murray,  UT  84107
Correspondent Contact DREW D WEAVER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/24/1991
Decision Date 08/16/1991
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
Recalls CDRH Recalls
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