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 K983554
Device Name ALLDRESS, ABSORBENT FILM DRESSING
Applicant
Molnlycke Health Care, Inc.
500 Baldwin Tower
Eddystone,  PA  19022
Applicant Contact MIGUEL A NEGRON
Correspondent
Molnlycke Health Care, Inc.
500 Baldwin Tower
Eddystone,  PA  19022
Correspondent Contact MIGUEL A NEGRON
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/13/1998
Decision Date 11/10/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-