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 powered laser surgical instrument
510(k) Number K051113
Device Name QUANTA SYSTEM ETRNA GIOVINEZZA
Applicant
QUANTA SYSTEM, S.P.A.
10 ELIZABETH DRIVE
CHELMSFORD,  MA  01824
Applicant Contact GEORGE CHO
Correspondent
QUANTA SYSTEM, S.P.A.
10 ELIZABETH DRIVE
CHELMSFORD,  MA  01824
Correspondent Contact GEORGE CHO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/02/2005
Decision Date 01/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-