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 tape and bandage, adhesive
510(k) Number K914315
Device Name OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
Applicant
MEDICAL DYNAMICS, INC.
99 INVERNESS DR., EAST
ENGLEWOOD,  CO  80112
Applicant Contact JO BREHM
Correspondent
MEDICAL DYNAMICS, INC.
99 INVERNESS DR., EAST
ENGLEWOOD,  CO  80112
Correspondent Contact JO BREHM
Regulation Number880.5240
Classification Product Code
KGX  
Date Received09/05/1991
Decision Date 03/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-