Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name insufflator, laparoscopic
510(k) Number K073452
Device Name MODIFICATION TO: ARAGON SURGICAL LAPCAP
Applicant
ARAGON SURGICAL INC.
1810 EMBARCADERO ROAD, SUITE B
PALO ALTO,  CA  94303
Applicant Contact ALAN CURTIS
Correspondent
ARAGON SURGICAL INC.
1810 EMBARCADERO ROAD, SUITE B
PALO ALTO,  CA  94303
Correspondent Contact ALAN CURTIS
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/10/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-