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 forceps, biopsy, electric
510(k) Number K955052
Device Name OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact SUBHASH PATEL
Correspondent
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact SUBHASH PATEL
Regulation Number876.4300
Classification Product Code
KGE  
Date Received11/06/1995
Decision Date 01/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-