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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Surgical, General & Plastic Surgery
510(k) Number K926513
Device Name MOLLER-WEDEL OPERATING MICROSCOPE
Applicant
Moeller Microsurgical, Inc.
40 Woodbridge Ave.
Metuchen,  NJ  08840
Applicant Contact RICHARD MONTGOMERY
Correspondent
Moeller Microsurgical, Inc.
40 Woodbridge Ave.
Metuchen,  NJ  08840
Correspondent Contact RICHARD MONTGOMERY
Regulation Number878.4700
Classification Product Code
FSO  
Date Received12/30/1992
Decision Date 06/22/1993
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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