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 bronchoscope (flexible or rigid)
510(k) Number K962485
Device Name OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact BARRY E SANDS
Correspondent
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact BARRY E SANDS
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received06/26/1996
Decision Date 08/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-