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 Laryngoscope, Rigid
510(k) Number K915161
Device Name AUGUSTINE FIBEROPTIC LARYNGOSCOPE
Applicant
Augustine Medical, Inc.
10393 W. 70th St.
Eden Prairie,  MN  55344
Applicant Contact SCOTT D AUGUSTINE
Correspondent
Augustine Medical, Inc.
10393 W. 70th St.
Eden Prairie,  MN  55344
Correspondent Contact SCOTT D AUGUSTINE
Regulation Number868.5540
Classification Product Code
CCW  
Date Received11/14/1991
Decision Date 05/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-