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 Instrument, Biopsy
510(k) Number K934371
Device Name BIP MULTI MODIFICATION
Applicant
Bip USA, Inc.
Carborundum Center
Suite 480, 345 Third St.
Niagara Falls,  NY  14303
Applicant Contact GARY HORNER
Correspondent
Bip USA, Inc.
Carborundum Center
Suite 480, 345 Third St.
Niagara Falls,  NY  14303
Correspondent Contact GARY HORNER
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/07/1993
Decision Date 04/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-