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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 K942304
Device Name MICROFLEX
Applicant
Moeller Microsurgical, Inc.
7 Industrial Park
Waldwick,  NJ  07463
Applicant Contact RICHARD W MONTEGOMERY
Correspondent
Moeller Microsurgical, Inc.
7 Industrial Park
Waldwick,  NJ  07463
Correspondent Contact RICHARD W MONTEGOMERY
Regulation Number878.4700
Classification Product Code
FSO  
Date Received05/13/1994
Decision Date 06/13/1994
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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