• 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 laser, neodymium:yag, pulmonary surgery
510(k) Number K852761
Device Name CILAS MODEL YM101
Applicant
INFRAMED, INC.
P.O. BOX 761
BROOKLINE VILLAGE,  MA  02147
Applicant Contact RAYMOND F FENNESSEY
Correspondent
INFRAMED, INC.
P.O. BOX 761
BROOKLINE VILLAGE,  MA  02147
Correspondent Contact RAYMOND F FENNESSEY
Regulation Number874.4500
Classification Product Code
LLO  
Date Received06/28/1985
Decision Date 11/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-