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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 K050360
Device Name TULIP CONDOM
Applicant
Shanghai Latex Factory
1700 Huang Xing Rd.
Shanghai,  CN 200433
Applicant Contact LOU JI
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact LAURA L DANIELSON
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/14/2005
Decision Date 03/01/2005
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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