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 Anesthesia Conduction Kit
510(k) Number K971233
Device Name SOFT TIP EPIDURAL CATHETER KIT
Applicant
B. Braun Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact MARK S ALBERGE
Correspondent
B. Braun Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact MARK S ALBERGE
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received04/02/1997
Decision Date 10/17/1997
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-