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 K140483
Device Name ASAP OTC WOUND DRESSING GEL
Applicant
Abl Medical, LLC
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Applicant Contact Calley Herzog
Correspondent
Abl Medical, LLC
400 N. Washington St.
Suite 100
Alexandria,  VA  22314
Correspondent Contact Calley Herzog
Classification Product Code
FRO  
Date Received02/26/2014
Decision Date 05/20/2014
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-