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 Goniometer, Nonpowered
510(k) Number K926237
Device Name O'BRIEN GONIOMETER
Applicant
Sgarlato Laboratories, Inc.
100 O'Connor Dr., Suite 18
San Jose,  CA  95128
Applicant Contact THOMAS E SGARLATO
Correspondent
Sgarlato Laboratories, Inc.
100 O'Connor Dr., Suite 18
San Jose,  CA  95128
Correspondent Contact THOMAS E SGARLATO
Regulation Number888.1520
Classification Product Code
KQW  
Date Received12/11/1992
Decision Date 08/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-