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 laser, neodymium:yag, pulmonary surgery
510(k) Number K884815
Device Name SLT CLMD CONTACT LASER
Applicant
SURGICAL LASER TECHNOLOGIES, INC.
ONE GREAT VALLEY PKWY.
MALVERN,  PA  19355
Applicant Contact GIFFORD, R.N.
Correspondent
SURGICAL LASER TECHNOLOGIES, INC.
ONE GREAT VALLEY PKWY.
MALVERN,  PA  19355
Correspondent Contact GIFFORD, R.N.
Regulation Number874.4500
Classification Product Code
LLO  
Date Received11/17/1988
Decision Date 12/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-