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 instrument, surgical, disposable
510(k) Number K831118
Device Name PMT-OPTICA LINE
Applicant
PMT, Inc.
Box 464
Hopkins,  MN  55343
Applicant Contact Alfred A Iversen
Correspondent
PMT, Inc.
Box 464
Hopkins,  MN  55343
Correspondent Contact Alfred A Iversen
Regulation Number878.4800
Classification Product Code
KDC  
Date Received04/05/1983
Decision Date 01/25/1984
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
-
-