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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Uterine
510(k) Number K935822
Device Name PHASE I CURETTE
Applicant
Phase I Corp.
29 High St. Unit O
Norwalk,  CT  06851
Applicant Contact SUSAN C VACCARO
Correspondent
Phase I Corp.
29 High St. Unit O
Norwalk,  CT  06851
Correspondent Contact SUSAN C VACCARO
Regulation Number884.4530
Classification Product Code
HCY  
Date Received12/03/1993
Decision Date 04/28/1994
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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