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 K863785
Device Name MAKLER CATHETER
Applicant
I M, INC.
P.O. BOX 658
FAIRFIELD,  NJ  07004
Applicant Contact AMIR PORAT
Correspondent
I M, INC.
P.O. BOX 658
FAIRFIELD,  NJ  07004
Correspondent Contact AMIR PORAT
Regulation Number884.5250
Classification Product Code
HDR  
Date Received09/26/1986
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
-
-