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 Dressing, Wound, Drug
510(k) Number K092878
Device Name PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE
Applicant
Prugen IP Holdings, Inc.
8711 E Pinnacle Peak Rd.
Suite C-201, Pmb 225
Scottsdale,  AZ  85255
Applicant Contact ROBERT L KNECHTEL
Correspondent
Prugen IP Holdings, Inc.
8711 E Pinnacle Peak Rd.
Suite C-201, Pmb 225
Scottsdale,  AZ  85255
Correspondent Contact ROBERT L KNECHTEL
Classification Product Code
FRO  
Date Received09/18/2009
Decision Date 01/15/2010
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-