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 Sleeve, Limb, Compressible
510(k) Number K141360
Device Name TRIPLEPLAY PRO
Applicant
Wildcat Medical, Inc.
1638 S. Main St.
Tulsa,  OK  74119
Applicant Contact MIKE BARTLETT
Correspondent
Wildcat Medical, Inc.
1638 S. Main St.
Tulsa,  OK  74119
Correspondent Contact MIKE BARTLETT
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/23/2014
Decision Date 06/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-