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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Orthopedic
510(k) Number K983882
Device Name MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400
Applicant
Micro-Medical Devices, Inc.
11000 Cedar Ave.
Suite 445
Cleveland,  OH  44106
Applicant Contact JIM OHNECK
Correspondent
Micro-Medical Devices, Inc.
11000 Cedar Ave.
Suite 445
Cleveland,  OH  44106
Correspondent Contact JIM OHNECK
Regulation Number878.4800
Classification Product Code
HXR  
Date Received11/02/1998
Decision Date 03/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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