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 stylet, tracheal tube
510(k) Number K933598
Device Name ENDOSTAR(TM) STYLET
Applicant
FIBEROPTIC MEDICAL PRODUCTS, INC.
5100 TILGHMAN ST., SUITE 300
ALLENTOWN,  PA  18104
Applicant Contact RICHARD W HOLT
Correspondent
FIBEROPTIC MEDICAL PRODUCTS, INC.
5100 TILGHMAN ST., SUITE 300
ALLENTOWN,  PA  18104
Correspondent Contact RICHARD W HOLT
Regulation Number868.5790
Classification Product Code
BSR  
Date Received07/26/1993
Decision Date 01/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-