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 Indicator, Physical/Chemical Sterilization Process
510(k) Number K971971
Device Name BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK
Applicant
Board of Directors, Albert Browne , Ltd.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J. M. NOLTE
Correspondent
Board of Directors, Albert Browne , Ltd.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J. M. NOLTE
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received05/29/1997
Decision Date 07/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-