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 K945901
Device Name DIRECT VIEW 2001 FIBERLIGHT
Applicant
Mercury Medical
11300-A 49th St. N.
Clearwater,  FL  34622
Applicant Contact KATHY L HANN
Correspondent
Mercury Medical
11300-A 49th St. N.
Clearwater,  FL  34622
Correspondent Contact KATHY L HANN
Regulation Number868.5540
Classification Product Code
CCW  
Date Received12/02/1994
Decision Date 12/27/1994
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
-
-