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 Screen, Tangent, Projection, Battery-Powered
510(k) Number K924753
Device Name BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE
Applicant
Bioenterics Corp.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Applicant Contact DELORES GRAHAM
Correspondent
Bioenterics Corp.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Correspondent Contact DELORES GRAHAM
Regulation Number886.1810
Classification Product Code
HMJ  
Date Received09/22/1992
Decision Date 12/15/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-