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 Light, Surgical, Fiberoptic
510(k) Number K922820
Device Name WOODBINE XT350, XENON ARC LIGHT SOURCE
Applicant
Woodbine Ptical Corp.
685 S. St.
Wrentham,  MA  02093
Applicant Contact ROBERT H SEGERSTEN
Correspondent
Woodbine Ptical Corp.
685 S. St.
Wrentham,  MA  02093
Correspondent Contact ROBERT H SEGERSTEN
Regulation Number878.4580
Classification Product Code
FST  
Date Received06/11/1992
Decision Date 09/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-