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 K920090
Device Name BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET
Applicant
HELIX MEDICAL, INC.
210 SANTA BARBERA ST.
SANTA BARBERA,  CA  93101
Applicant Contact CHRISTINE EMANUEL
Correspondent
HELIX MEDICAL, INC.
210 SANTA BARBERA ST.
SANTA BARBERA,  CA  93101
Correspondent Contact CHRISTINE EMANUEL
Regulation Number874.3730
Classification Product Code
EWL  
Date Received01/08/1992
Decision Date 09/10/1992
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
-
-