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 K971918
Device Name AMERIGEL OINTMENT SATURATED WOUND DRESSING
Applicant
Amerx Health Care Corp.
1150 Cleveland St.
Suite 410
Clearwater,  FL  34615
Applicant Contact RON MADDIX
Correspondent
Amerx Health Care Corp.
1150 Cleveland St.
Suite 410
Clearwater,  FL  34615
Correspondent Contact RON MADDIX
Classification Product Code
MGQ  
Date Received05/23/1997
Decision Date 08/12/1997
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-