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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 K990387
Device Name ENDOMETRIAL SAMPLER
Applicant
U.A. MEDICAL PRODUCTS, INC.
9303-G2 MONROE RD.
CHARLOTTE,  NC  28270
Applicant Contact FANISH ENGINEER
Correspondent
U.A. MEDICAL PRODUCTS, INC.
9303-G2 MONROE RD.
CHARLOTTE,  NC  28270
Correspondent Contact FANISH ENGINEER
Regulation Number884.1175
Classification Product Code
HHK  
Date Received02/08/1999
Decision Date 04/20/1999
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
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