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 Accessories, Blood Circuit, Hemodialysis
510(k) Number K920614
Device Name HEMO-BAND
Applicant
Innovations IN Access, Inc.
18603 Willamette Dr.
West Linn,  OR  97068
Applicant Contact TOM TRIBOU
Correspondent
Innovations IN Access, Inc.
18603 Willamette Dr.
West Linn,  OR  97068
Correspondent Contact TOM TRIBOU
Regulation Number876.5820
Classification Product Code
KOC  
Date Received02/11/1992
Decision Date 07/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-