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 beads, hydrophilic, for wound exudate absorption
510(k) Number K874552
Device Name ENVISAN PAD
Applicant
MARION LABORATORIES, INC.
P.O. BOX 9627
KANSAS CITY,  MI  64134
Applicant Contact WILLIAM H GUINTY
Correspondent
MARION LABORATORIES, INC.
P.O. BOX 9627
KANSAS CITY,  MI  64134
Correspondent Contact WILLIAM H GUINTY
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received11/04/1987
Decision Date 01/22/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-