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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
510(k) Number K852586
Device Name CROMIC SURGICAL MICROSCOPE MODEL MC-1
Applicant
SELTREX, CORP.
450 SAN ANTONIO RD., STE. 33
PALO ALTO,  CA  94306
Applicant Contact DI TOMAS
Correspondent
SELTREX, CORP.
450 SAN ANTONIO RD., STE. 33
PALO ALTO,  CA  94306
Correspondent Contact DI TOMAS
Regulation Number878.4700
Classification Product Code
HRM  
Date Received06/18/1985
Decision Date 07/30/1985
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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