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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 K963593
Device Name IMT LOUPE-COLPOSCOPE
Applicant
Inventive Medical Technology
4361 Baildon Rd.
Trappe,  MD  21673 -1807
Applicant Contact THEODORE P REED
Correspondent
Inventive Medical Technology
4361 Baildon Rd.
Trappe,  MD  21673 -1807
Correspondent Contact THEODORE P REED
Regulation Number884.1630
Classification Product Code
HEX  
Date Received09/09/1996
Decision Date 04/22/1997
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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