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 Restraint, Protective
510(k) Number K080448
Device Name CENTURION PROTECTIVE RESTRAINT, SCR SERIES
Applicant
TRI-STATE HOSPITAL SUPPLY CORP.
301 CATRELL DR.
HOWELL,  MI  48843
Applicant Contact MATTHEW K PRICE
Correspondent
TRI-STATE HOSPITAL SUPPLY CORP.
301 CATRELL DR.
HOWELL,  MI  48843
Correspondent Contact MATTHEW K PRICE
Regulation Number880.6760
Classification Product Code
FMQ  
Date Received02/19/2008
Decision Date 08/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-