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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 K081413
Device Name TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
Applicant
Dailian Latex Company, Ltd.
# 188 Malan N. St.
Shahekou District
Dailian City, Liaoning,  CN 116021
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/20/2008
Decision Date 10/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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