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 Catheters, Salpingography
510(k) Number K953314
Device Name CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM
Applicant
Conceptus, Inc.
1021 Howard Ave.
San Carlos,  CA  94070
Applicant Contact ALEXIS BALL
Correspondent
Conceptus, Inc.
1021 Howard Ave.
San Carlos,  CA  94070
Correspondent Contact ALEXIS BALL
Regulation Number884.4530
Classification Product Code
MOV  
Date Received07/12/1995
Decision Date 07/28/1995
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
-
-