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510(k) K933508

Device
REFLEX SDD SURGICAL STAPLER
Applicant
RICHARD-ALLAN MEDICAL
510(k) number
K933508
Product code
GEF  
Decision
Substantially Equivalent (SESE)
Decision date
1993-11-23
Date received
1993-07-20
Regulation
878.4800
Classification name
Applier, Staple, Surgical,
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JULIE POWELL
Address
8850m89, Box 351 Richland MI US 49083 49083

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GEF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K915670MICROAIRE MODEL 2600Microaire1992-03-18
K854568V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAPAmerican V. Mueller1985-12-02
K8238883M FRASCIA STAPLING SYSTEM3M Company1983-01-09

Legacy Summary#

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FDA Review#

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