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 Hysteroscope (And Accessories)
510(k) Number K092421
Device Name ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
Applicant
Gimmi GmbH
One Scanlan Plz.
Saint Paul,  MN  55107
Applicant Contact KEN BLAKE
Correspondent
Gimmi GmbH
One Scanlan Plz.
Saint Paul,  MN  55107
Correspondent Contact KEN BLAKE
Regulation Number884.1690
Classification Product Code
HIH  
Date Received08/07/2009
Decision Date 02/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-