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 Laparoscope, Gynecologic (And Accessories)
510(k) Number K943810
Device Name IMAGYN MICROLAP INTRODUCER
Applicant
IMAGYN MEDICAL, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL,  CA  92656 -3917
Applicant Contact ROBERT J CHIN
Correspondent
IMAGYN MEDICAL, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL,  CA  92656 -3917
Correspondent Contact ROBERT J CHIN
Regulation Number884.1720
Classification Product Code
HET  
Date Received08/05/1994
Decision Date 01/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-