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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 K070812
Device Name DISPOSABLE LAPAROSCOPIC INSTRUMENT
Applicant
Modern Medical Equipment Mfg., Ltd.
1705 Dabney Rd.
Richmond,  VA  23230
Applicant Contact ROBERT STILLMAN
Correspondent
Modern Medical Equipment Mfg., Ltd.
1705 Dabney Rd.
Richmond,  VA  23230
Correspondent Contact ROBERT STILLMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/26/2007
Decision Date 09/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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