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 K934115
Device Name 3000 ELECTRONIC INSUFFLATOR MODIFICATION
Applicant
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Applicant Contact TODD J POLK
Correspondent
CABOT MEDICAL CORP.
2021 CABOT BOULEVARD WEST
LANGHORNE,  PA  19047
Correspondent Contact TODD J POLK
Regulation Number884.1730
Classification Product Code
HIF  
Date Received08/24/1993
Decision Date 03/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-