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 Larynx, Artificial (Battery-Powered)
510(k) Number K931371
Device Name DENRICK SPEECH AID (DR-1)
Applicant
Denrick Corp.
469 Ena Rd., Suite 3003
Honolulu,  HI  96815
Applicant Contact DENNIS KOSANKE
Correspondent
Denrick Corp.
469 Ena Rd., Suite 3003
Honolulu,  HI  96815
Correspondent Contact DENNIS KOSANKE
Regulation Number874.3375
Classification Product Code
ESE  
Date Received03/17/1993
Decision Date 08/25/1993
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
-
-