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, Manual, Surgical, General Use
510(k) Number K943968
Device Name TUNNELER
Applicant
Denver Biomedicals, Inc.
6851 Highway 73
Evergreen,  CO  80439
Applicant Contact LYNNE LEONARD
Correspondent
Denver Biomedicals, Inc.
6851 Highway 73
Evergreen,  CO  80439
Correspondent Contact LYNNE LEONARD
Regulation Number878.4800
Classification Product Code
MDM  
Date Received08/15/1994
Decision Date 03/01/1995
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
-
-