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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 K915491
Device Name CURELLE
Applicant
Bioteque Corp.
5` Rainlily Rd.
Levittown,  PA  19056
Applicant Contact DENIS DORSEY
Correspondent
Bioteque Corp.
5` Rainlily Rd.
Levittown,  PA  19056
Correspondent Contact DENIS DORSEY
Regulation Number884.1175
Classification Product Code
HHK  
Date Received12/06/1991
Decision Date 11/04/1992
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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