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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K070651
Device Name ARAGON SURGICAL LAPCAP
Applicant
Aragon Surgical, Inc.
1810 Embarcadero Rd., Suite B
Palo Alto,  CA  94303
Applicant Contact ALAN CURTIS
Correspondent
Aragon Surgical, Inc.
1810 Embarcadero Rd., Suite B
Palo Alto,  CA  94303
Correspondent Contact ALAN CURTIS
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/09/2007
Decision Date 05/30/2007
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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