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 prosthesis, laryngeal (taub)
510(k) Number K945287
Device Name INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE
Applicant
HELIX MEDICAL, INC.
1110 MARK AVE.
CARPINTERIA,  CA  93013
Applicant Contact STEPHEN W LAGUETTE
Correspondent
HELIX MEDICAL, INC.
1110 MARK AVE.
CARPINTERIA,  CA  93013
Correspondent Contact STEPHEN W LAGUETTE
Regulation Number874.3730
Classification Product Code
EWL  
Date Received10/31/1994
Decision Date 12/09/1994
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
-
-