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 Bandage, Liquid
510(k) Number K940407
Device Name KALTOGEL WOUND DRESSING
Applicant
CALGON CORP.
SUB. MERCK & CO., INC.
5035 MANCHESTER AVE.
ST. LOUIS,  MO  63110
Applicant Contact ANNE SCHMITT
Correspondent
CALGON CORP.
SUB. MERCK & CO., INC.
5035 MANCHESTER AVE.
ST. LOUIS,  MO  63110
Correspondent Contact ANNE SCHMITT
Regulation Number880.5090
Classification Product Code
KMF  
Date Received01/27/1994
Decision Date 04/07/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-