FDA.reportPublic FDA data

510(k) K981981

Device
ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19
Applicant
Boston Scientific Corp
510(k) number
K981981
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-03
Date received
1998-06-05
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
STEVE JWANOUSKOS
Address
2710 Orchard Pkwy. San Jose CA US 95134 95134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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