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 Bath, Incubators/Water, All
510(k) Number K875275
Device Name WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER
Applicant
Sterling Drug, Inc.
90 Park Ave.
New York,  NY  10016
Applicant Contact CARL E CALCAGNI
Correspondent
Sterling Drug, Inc.
90 Park Ave.
New York,  NY  10016
Correspondent Contact CARL E CALCAGNI
Regulation Number866.2540
Classification Product Code
JTQ  
Date Received12/24/1987
Decision Date 01/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-