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 Hearing Aid, Air-Conduction, Prescription
510(k) Number K931041
Device Name STAR 42 PP-SP, STAR 42 PP-SL (T100)
Applicant
MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2029
Applicant Contact THOMAS A DOLD
Correspondent
MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2029
Correspondent Contact THOMAS A DOLD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/01/1993
Decision Date 06/01/1993
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
Predetermined Change
Control Plan Authorized		 No
-
-