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, Disposable
510(k) Number K963689
Device Name RECOVER ADULT VEIN WARMER
Applicant
Florida Medical Industries, Inc.
40178 U.S. 19 N.
Tarpon Springs,  FL  34689
Applicant Contact PATRICK J LAMB
Correspondent
Florida Medical Industries, Inc.
40178 U.S. 19 N.
Tarpon Springs,  FL  34689
Correspondent Contact PATRICK J LAMB
Regulation Number890.5710
Classification Product Code
IMD  
Date Received09/16/1996
Decision Date 12/12/1996
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
-
-