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 surgeon's gloves
510(k) Number K031130
Device Name YA MEI FIRST AID KIT
Applicant
YA MEI TECHNOLOGY CO., LTD.
13 RED FOX LN.
LITTLETON,  CO  80127
Applicant Contact Kevin Walls
Correspondent
YA MEI TECHNOLOGY CO., LTD.
13 RED FOX LN.
LITTLETON,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
LRR  
Date Received04/09/2003
Decision Date 06/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-