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 drape, surgical
510(k) Number K920340
Device Name SUTURE REMOVAL KIT
Applicant
MEDIKMARK, INC.
333 WEST WACKER DR.
SUITE 2600
CHICAGO,  IL  60606
Applicant Contact RICHARD O WOOD
Correspondent
MEDIKMARK, INC.
333 WEST WACKER DR.
SUITE 2600
CHICAGO,  IL  60606
Correspondent Contact RICHARD O WOOD
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/24/1992
Decision Date 04/23/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-