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 K810480
Device Name SCANLAN SUTURE BOOTS
Applicant
Scanlan Intl., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Scanlan Intl., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number876.5820
Classification Product Code
KOC  
Date Received02/23/1981
Decision Date 03/13/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-