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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 K040189
Device Name ENDOMETRIAL SAMPLING SYRINGE
Applicant
ROCKET MEDICAL PLC
1151 HOPE ST.
STAMFORD,  CT  06907
Applicant Contact R. KEEN
Correspondent
ROCKET MEDICAL PLC
1151 HOPE ST.
STAMFORD,  CT  06907
Correspondent Contact R. KEEN
Regulation Number884.1175
Classification Product Code
HHK  
Date Received01/28/2004
Decision Date 10/04/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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