• 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 hearing aid, air-conduction, prescription
510(k) Number K902351
Device Name CUSTOM ITE HEARING AID MODELS C AND M
Applicant
OTICON CORP.
29 SCHOOLHOUSE RD.
P.O. BOX 6724
SOMERSET,  NJ  08873
Applicant Contact PREBEN BRUNVED
Correspondent
OTICON CORP.
29 SCHOOLHOUSE RD.
P.O. BOX 6724
SOMERSET,  NJ  08873
Correspondent Contact PREBEN BRUNVED
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/29/1990
Decision Date 06/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-