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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 K020628
Device Name CURELLE, PREFERRED CURELLE, CUTEQ 2.5
Applicant
Bioteque America, Inc.
340 E. Maple Ave., #204-C
Langhorne,  PA  19047
Applicant Contact DENIS DORSEY
Correspondent
Bioteque America, Inc.
340 E. Maple Ave., #204-C
Langhorne,  PA  19047
Correspondent Contact DENIS DORSEY
Regulation Number884.1175
Classification Product Code
HHK  
Date Received02/26/2002
Decision Date 05/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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