FDA.reportPublic FDA data

510(k) K926237

Device
O'BRIEN GONIOMETER
Applicant
SGARLATO LABORATORIES, INC.
510(k) number
K926237
Product code
KQW  
Decision
Substantially Equivalent (SESE)
Decision date
1993-08-02
Date received
1992-12-11
Regulation
888.1520
Classification name
Goniometer, Nonpowered
Medical specialty
Orthopedic
Review panel
Neurology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
THOMAS E SGARLATO
Address
100 O'Connor Dr., Suite 18 San Jose CA US 95128 95128

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KQW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K901744DOBBHOFF(R) RETRIEVAL FORCEPSBiosearch Medical Products, Inc.1990-07-03
K870767THE (CROM) TESTERTwin City Surgical, Inc.1987-03-17
K850082HAND HELD GONIOMETERChattanooga Group, Inc.1985-04-04
K831550FINGER BONIOMETER BK7506Fred Sammons, Inc.1983-06-24
K812778THE TELOS EQUIPMENTThe Telos Co.1981-12-08
K810441UNIVERSAL GONIMETERFred Sammons, Inc.1981-02-27
K801715BK-7497 BULB DYNAMOMETERFred Sammons, Inc.1980-08-04
K801716BK-7505 RADIOPAQUE GONIOMETER, 8Fred Sammons, Inc.1980-08-04
K801717BK-7511 BRASS GONIOMETERFred Sammons, Inc.1980-08-04
K801718BK-7513 STAINLESS STEEL GONIOMETERFred Sammons, Inc.1980-08-04
K760301GONIOMETER, MED. INTER. STAND. BK-7512Fred Sammons, Inc.1976-09-08
K760302GONIOMETER, INTER. STAND. LARGE, BK7514Fred Sammons, Inc.1976-09-08

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases