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 Wound Dressings Containing Topical Analgesics
510(k) Number K020540
Device Name REGENECARE WOUND GEL
Applicant
Mpm Medical., Inc.
2301 Crown Court
Irving,  TX  75038
Applicant Contact PAUL R MILLER
Correspondent
Mpm Medical., Inc.
2301 Crown Court
Irving,  TX  75038
Correspondent Contact PAUL R MILLER
Classification Product Code
SEJ  
Date Received02/19/2002
Decision Date 11/01/2002
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-