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 Formalin, Neutral Buffered
510(k) Number K853497
Device Name PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN
Applicant
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Applicant Contact KEN URBAN
Correspondent
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Correspondent Contact KEN URBAN
Regulation Number864.4010
Classification Product Code
IFP  
Date Received08/20/1985
Decision Date 08/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-