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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K945265
Device Name OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES
Applicant
Optus, Inc.
1200 S. Parker Rd.
Denver,  CO  80231
Applicant Contact PETER DUFFY
Correspondent
Optus, Inc.
1200 S. Parker Rd.
Denver,  CO  80231
Correspondent Contact PETER DUFFY
Regulation Number884.1690
Classification Product Code
HIH  
Date Received10/28/1994
Decision Date 09/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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