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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Battery-Powered
510(k) Number K023506
Device Name SURGICAL MEDICAL DEVICE CAUTERY
Applicant
Modern Medical Equipment Mfg., Ltd.
1705 Dabney Rd.
Richmond,  VA  23230
Applicant Contact ROGER STRUBE
Correspondent
Modern Medical Equipment Mfg., Ltd.
1705 Dabney Rd.
Richmond,  VA  23230
Correspondent Contact ROGER STRUBE
Regulation Number886.4115
Classification Product Code
HQP  
Date Received10/18/2002
Decision Date 01/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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