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510(k) K896383

Device
DISPOSABLE EXTERNAL CLAMPS
Applicant
GALENICA ENTERPRISES, INC.
510(k) number
K896383
Product code
GDI  
Decision
Substantially Equivalent (SESE)
Decision date
1989-12-06
Date received
1989-11-06
Regulation
878.4800
Classification name
Dissector, Surgical, General & Plastic Surgery
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BETTY MAILHOT
Address
C.P. 13 Ste-Therese Quebec Canada J7e 4h7 CA

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K850288HEPATIC PARENCHYMAL SUCTION DISSECTORBeecher Medical Diagnostic Instrumentation1985-03-18
K831912ROUND-BEEHIVE- DISSECTORS 3/8Ormed Mfg., Inc.1983-10-31
K822569TYMPANOPLASTY & SKIN DISSECTORSKelleher Corp.1982-10-06
K803292FIELD SUCTION DISSECTORV. Mueller O.V. Baxter Healthcare Corp.1981-01-29
K791870DISPOSABLE SPECIALITY SPONGESCarwild Corp.1979-11-05
K791703TEW BYPASS INSTRUMENTS & DISSECTING KITEdward Weck, Inc.1979-10-04

Legacy Summary#

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FDA Review#

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