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 K950255
Device Name ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM
Applicant
Argus Medical Co., Inc.
385 S. Lemon Ave.
Suite E-219
Walnut,  CA  91789
Applicant Contact WILLIAM MEYER
Correspondent
Argus Medical Co., Inc.
385 S. Lemon Ave.
Suite E-219
Walnut,  CA  91789
Correspondent Contact WILLIAM MEYER
Regulation Number884.1690
Classification Product Code
HIH  
Date Received01/23/1995
Decision Date 08/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-