• 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 K882721
Device Name ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR
Applicant
HEAR-O INC. C/O L.P. LEALE & ASSOC.
1849 BONANAZA ST.
WALNUT CREEK,  CA  94596
Applicant Contact L. P LEALE
Correspondent
HEAR-O INC. C/O L.P. LEALE & ASSOC.
1849 BONANAZA ST.
WALNUT CREEK,  CA  94596
Correspondent Contact L. P LEALE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/01/1988
Decision Date 09/15/1988
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
-
-