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 labor and delivery kit
510(k) Number K940518
Device Name C-SECTION TRAY
Applicant
CUSH MEDICAL PRODUCTS
P.O. BOX 247
881 MOUNTAIN VIEW DRIVE
PINEY FLATS,  TN  37686
Applicant Contact STEVE B JOHNSTON
Correspondent
CUSH MEDICAL PRODUCTS
P.O. BOX 247
881 MOUNTAIN VIEW DRIVE
PINEY FLATS,  TN  37686
Correspondent Contact STEVE B JOHNSTON
Regulation Number884.4530
Classification Product Code
MLS  
Date Received02/04/1994
Decision Date 08/18/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-