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 Pack, Hot Or Cold, Water Circulating
510(k) Number K073675
Device Name T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
Applicant
Gaymar Industries, Inc.
140 Pearl St., Suite 100
Buffalo,  NY  14202
Applicant Contact BETHANY J GILBERT
Correspondent
Gaymar Industries, Inc.
140 Pearl St., Suite 100
Buffalo,  NY  14202
Correspondent Contact BETHANY J GILBERT
Regulation Number890.5720
Classification Product Code
ILO  
Date Received12/28/2007
Decision Date 05/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-