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 Instrument, Manual, General Obstetric-Gynecologic
510(k) Number K921730
Device Name C-SECTION PACK
Applicant
Medikmark, Inc.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Applicant Contact RICHARD O WOOD
Correspondent
Medikmark, Inc.
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Correspondent Contact RICHARD O WOOD
Regulation Number884.4520
Classification Product Code
KOH  
Date Received04/10/1992
Decision Date 06/15/1994
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
-
-