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 nasopharyngoscope (flexible or rigid)
510(k) Number K972450
Device Name FLEXTIP GRASPER
Applicant
ENDIUS, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact CYNTHIA J NOLTE
Correspondent
ENDIUS, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CYNTHIA J NOLTE
Regulation Number874.4760
Classification Product Code
EOB  
Subsequent Product Code
HRX  
Date Received06/30/1997
Decision Date 11/21/1997
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
-
-