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 K950395
Device Name THERMOCOOL SYSTEM
Applicant
Zimmer, Inc.
200 W. Ohio Ave.
Dover,  OH  44622
Applicant Contact PAULA OSORIO
Correspondent
Zimmer, Inc.
200 W. Ohio Ave.
Dover,  OH  44622
Correspondent Contact PAULA OSORIO
Regulation Number890.5720
Classification Product Code
ILO  
Date Received02/01/1995
Decision Date 08/18/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-