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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
510(k) Number K933310
Device Name MICRINS CONTRAST BACKGROUND MATERIAL
Applicant
Micrins Surgical, Inc.
28438 Ballard Dr.
Lake Forest,  IL  60045
Applicant Contact BERNHARD TEITZ
Correspondent
Micrins Surgical, Inc.
28438 Ballard Dr.
Lake Forest,  IL  60045
Correspondent Contact BERNHARD TEITZ
Regulation Number878.4700
Classification Product Code
EPT  
Date Received07/07/1993
Decision Date 08/19/1993
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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