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 K954438
Device Name SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE
Applicant
Rms Div.
1247 Flordia Ave.
Palm Harbor,  FL  34683
Applicant Contact GEORGE D CRANTON
Correspondent
Rms Div.
1247 Flordia Ave.
Palm Harbor,  FL  34683
Correspondent Contact GEORGE D CRANTON
Regulation Number868.5540
Classification Product Code
CCW  
Date Received09/25/1995
Decision Date 12/29/1995
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
-
-