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 Analyzer, Gas, Argon, Gaseous-Phase
510(k) Number K880442
Device Name BRUSHRITE
Applicant
Pro Care Laboratories, Inc.
218 W. Park St.
West Point,  NE  68788
Applicant Contact EUGENE M MUELLER
Correspondent
Pro Care Laboratories, Inc.
218 W. Park St.
West Point,  NE  68788
Correspondent Contact EUGENE M MUELLER
Regulation Number868.1075
Classification Product Code
JEG  
Date Received02/02/1988
Decision Date 05/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-