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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colposcope (And Colpomicroscope)
510(k) Number K101141
Device Name SEILER COLPOSCOPE, MODELS 935, 955 AND 985
Applicant
Seiler Precision Microscopes
3433 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact DAN MEYER
Correspondent
Seiler Precision Microscopes
3433 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact DAN MEYER
Regulation Number884.1630
Classification Product Code
HEX  
Date Received04/22/2010
Decision Date 08/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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