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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Suction, Endometrial (And Accessories)
510(k) Number K854415
Device Name ENDOMETRIAL PIPELLE
Applicant
Unimar, Inc.
475 Danbury Rd.
Wilton,  CT  06897
Applicant Contact ANTHONY HEMMING
Correspondent
Unimar, Inc.
475 Danbury Rd.
Wilton,  CT  06897
Correspondent Contact ANTHONY HEMMING
Regulation Number884.1175
Classification Product Code
HHK  
Date Received11/04/1985
Decision Date 03/13/1986
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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