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 K983878
Device Name CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE
Applicant
E. BENSON HOOD LABORATORIES, INC.
575 WASHINGTON ST.
PEMBROKE,  MA  02359
Applicant Contact ANTHONY M SACCHETTI
Correspondent
E. BENSON HOOD LABORATORIES, INC.
575 WASHINGTON ST.
PEMBROKE,  MA  02359
Correspondent Contact ANTHONY M SACCHETTI
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received11/02/1998
Decision Date 01/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-