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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K083024
Device Name HYLATOPIC EMOLLIENT FOAM
Applicant
Collegium Pharmaceutical Incorporated
400 Highland Corporate Dr.
Cumberland,  RI  02864
Applicant Contact RONALD M GURGE
Correspondent
Collegium Pharmaceutical Incorporated
400 Highland Corporate Dr.
Cumberland,  RI  02864
Correspondent Contact RONALD M GURGE
Classification Product Code
MGQ  
Date Received10/09/2008
Decision Date 03/27/2009
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
-
-