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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 K862297
Device Name THE D & C PAD-SAC
Applicant
NU-GYN-TEK, INC.
P.O. BOX 75
OAKFIELD,  NY  14125
Applicant Contact JAEGER, M.D.
Correspondent
NU-GYN-TEK, INC.
P.O. BOX 75
OAKFIELD,  NY  14125
Correspondent Contact JAEGER, M.D.
Regulation Number884.4530
Classification Product Code
HCY  
Date Received06/17/1986
Decision Date 07/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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