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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 K850068
Device Name LUNE AU CURETTES
Applicant
Luneau Laboratories
2000 L. St. NW
Suite 715
Washington,  DC  20036
Applicant Contact CHAMBORD
Correspondent
Luneau Laboratories
2000 L. St. NW
Suite 715
Washington,  DC  20036
Correspondent Contact CHAMBORD
Regulation Number884.4530
Classification Product Code
HCY  
Date Received01/08/1985
Decision Date 04/08/1985
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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