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, Elastic
510(k) Number K840107
Device Name TUBE-BANDAGE FOR HUMAN DIGITS 200
Applicant
Zens Health Care Products
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Zens Health Care Products
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5075
Classification Product Code
FQM  
Date Received01/10/1984
Decision Date 04/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-