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 Adaptor, Bulbs, Miscellaneous, For Endoscope
510(k) Number K932128
Device Name CMI E-Z FLO BULB P.N. 701
Applicant
Columbia Medical & Surgical, Inc.
P.O. Box 5877
Bend,  OR  97708
Applicant Contact BEVERLEE LOUVRING
Correspondent
Columbia Medical & Surgical, Inc.
P.O. Box 5877
Bend,  OR  97708
Correspondent Contact BEVERLEE LOUVRING
Regulation Number876.1500
Classification Product Code
FFY  
Date Received05/03/1993
Decision Date 04/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-