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 K180305
Device Name Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
Applicant
Aquilabs Us, LLC
9205 NW 101st St.
Medley,  FL  33178
Applicant Contact Juan Salcedo
Correspondent
Aquilabs Us, LLC
9205 NW 101st St.
Medley,  FL  33178
Correspondent Contact Juan Salcedo
Classification Product Code
FRO  
Date Received02/02/2018
Decision Date 04/13/2018
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
-
-