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 K954164
Device Name HYSTEROSCOPE
Applicant
CONCEPTUS, INC.
1021 HOWARD AVE.
SAN CARLOS,  CA  94070
Applicant Contact CINDY DOMECUS
Correspondent
CONCEPTUS, INC.
1021 HOWARD AVE.
SAN CARLOS,  CA  94070
Correspondent Contact CINDY DOMECUS
Regulation Number884.1690
Classification Product Code
HIH  
Date Received09/05/1995
Decision Date 03/12/1996
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
-
-