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 face plate hearing aid
510(k) Number K897023
Device Name OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID
Applicant
AUDINA HEARING INSTRUMENT
150 WILDMERE ST.
LONGWOOD,  FL  32750
Applicant Contact FRANK J ROBILOTTA
Correspondent
AUDINA HEARING INSTRUMENT
150 WILDMERE ST.
LONGWOOD,  FL  32750
Correspondent Contact FRANK J ROBILOTTA
Regulation Number874.3300
Classification Product Code
LRB  
Date Received12/19/1989
Decision Date 03/16/1990
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
-
-