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 K050158
Device Name SINCLAIR SEBORRHEA EMULSION
Applicant
Sinclair Pharmaceuticals, Ltd.
Borough Rd.
Godalming, Surrey,  GB GU7 2AB
Applicant Contact MICHEAL KILLEEN
Correspondent
Sinclair Pharmaceuticals, Ltd.
Borough Rd.
Godalming, Surrey,  GB GU7 2AB
Correspondent Contact MICHEAL KILLEEN
Classification Product Code
FRO  
Subsequent Product Code
MGQ  
Date Received01/25/2005
Decision Date 10/11/2006
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-