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 coagulator, laparoscopic, unipolar (and accessories)
510(k) Number K101606
Device Name MICROMED PD-8K INSULATION DEFECT DETECTOR
Applicant
MCGAN TECHNOLOGY, LLC
410 RIDGE ROAD
MIDDLETOWN,  CT  06457
Applicant Contact JACK GANIS
Correspondent
MCGAN TECHNOLOGY, LLC
410 RIDGE ROAD
MIDDLETOWN,  CT  06457
Correspondent Contact JACK GANIS
Regulation Number884.4160
Classification Product Code
HFG  
Date Received06/08/2010
Decision Date 10/01/2010
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
-
-