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 K932291
Device Name EUTRA GEL FOR WOUND DRESSING
Applicant
Swiss American Products, Inc.
4315 Alpha Rd.
Dallas,  TX  75244
Applicant Contact EUGENE STUBBS
Correspondent
Swiss American Products, Inc.
4315 Alpha Rd.
Dallas,  TX  75244
Correspondent Contact EUGENE STUBBS
Classification Product Code
MGQ  
Date Received05/10/1993
Decision Date 07/18/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-