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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K993887
Device Name ALATECH LATEX CONDOM
Applicant
ALATECH HEALTHCARE, LLC.
595 EAST LAWRENCE HARRIS HWY
SLOCOMB,  AL  36375
Applicant Contact WAYNE L GAINEY
Correspondent
ALATECH HEALTHCARE, LLC.
595 EAST LAWRENCE HARRIS HWY
SLOCOMB,  AL  36375
Correspondent Contact WAYNE L GAINEY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/16/1999
Decision Date 12/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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