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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Vaginal
510(k) Number K823517
Device Name THE KLINE APPLICATOR
Applicant
KLINE TECHNOLOGIES, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KLINE TECHNOLOGIES, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.4520
Classification Product Code
HGD  
Date Received11/29/1982
Decision Date 01/18/1983
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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