FDA.reportPublic FDA data

510(k) K823888

Device
3m Frascia Stapling System
Applicant
3M COMPANY
510(k) number
K823888
Product code
GEF
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-09
Date received
1982-12-27
Regulation
878.4800
Classification name
Applier, Staple, Surgical,
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
8124 Pacific Ave. White City OR US 97503 97503

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GEF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933508REFLEX SDD SURGICAL STAPLERRichard-Allan Medical1993-11-23
K915670MICROAIRE MODEL 2600Microaire1992-03-18
K854568V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAPAmerican V. Mueller1985-12-02