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 Elastomer, Silicone, For Scar Management
510(k) Number K930409
Device Name PMT(R) SILICONE GEL SHEETING MODEL 3505-1
Applicant
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Applicant Contact TIMOTHY KEETER
Correspondent
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Correspondent Contact TIMOTHY KEETER
Regulation Number878.4025
Classification Product Code
MDA  
Date Received01/26/1993
Decision Date 09/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-