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 Cement, Ear, Nose And Throat
510(k) Number K011338
Device Name OTO-CEM
Applicant
OTOTECH, INC.
1625 K STREET, NW
SUITE 1000
WASHINGTON,  DC  20006
Applicant Contact MICHAEL G FARROW
Correspondent
OTOTECH, INC.
1625 K STREET, NW
SUITE 1000
WASHINGTON,  DC  20006
Correspondent Contact MICHAEL G FARROW
Regulation Number872.3275
Classification Product Code
NEA  
Date Received05/02/2001
Decision Date 09/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-