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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K032091
Device Name SMART KLAMP VARIOUS BY SIZE
Applicant
Emergogroup, Inc.
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Applicant Contact RENE' VAN DE ZANDE
Correspondent
Emergogroup, Inc.
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Correspondent Contact RENE' VAN DE ZANDE
Regulation Number884.4530
Classification Product Code
HFX  
Date Received07/07/2003
Decision Date 03/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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