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 I.V. Start Kit
510(k) Number K926031
Device Name PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT
Applicant
Brigam Medical, Inc.
393 E. Fleming Dr.
Post Office Drawer 550
Morganton,  NC  28655
Applicant Contact KELLY L HEATH
Correspondent
Brigam Medical, Inc.
393 E. Fleming Dr.
Post Office Drawer 550
Morganton,  NC  28655
Correspondent Contact KELLY L HEATH
Regulation Number880.5200
Classification Product Code
LRS  
Date Received12/01/1992
Decision Date 06/07/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-