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 Bandage, Liquid
510(k) Number K944491
Device Name DERMAGRAN HYDROPHILIC OINTMENT
Applicant
Derma Sciences, Inc.
121 W. Grace St.
Old Forge,  PA  18518
Applicant Contact MARY G CLARK
Correspondent
Derma Sciences, Inc.
121 W. Grace St.
Old Forge,  PA  18518
Correspondent Contact MARY G CLARK
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/13/1994
Decision Date 11/22/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-