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 Cap, Cervical
510(k) Number K861305
Device Name INTRAUTERINE CATHETER
Applicant
Ram Development
28 Remez St.
Nes-Ziona 70400
Israel,  IL
Applicant Contact ITZIK RABINOVITZ
Correspondent
Ram Development
28 Remez St.
Nes-Ziona 70400
Israel,  IL
Correspondent Contact ITZIK RABINOVITZ
Regulation Number884.5250
Classification Product Code
HDR  
Date Received04/07/1986
Decision Date 12/11/1986
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
-
-