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510(k) K000079

Device
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
Applicant
NIKOMED U.S.A., INC.
510(k) number
K000079
Product code
HAM  
Decision
Substantially Equivalent (SESE)
Decision date
2000-02-04
Date received
2000-01-11
Regulation
878.4400
Classification name
Apparatus, Electrosurgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ELAINE DUNCAN
Address
P.O. Box 560 Stillwater MN US 55082 55082

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HAM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153472Quiver Laparoscopic ExtendableItl Corporation Pty, Ltd.2016-06-23
K993306NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)Paladin Medical, Inc.1999-11-03
K945861BERGEN 710 ESUBergen Mfg.1995-03-01
K913300LAPAROSTAT(TM)Cook Ob/Gyn1992-04-02
K920100GSU HANDPIECE ADAPTERBeacon Laboratories, Inc.1992-02-03
K911353EMC MODEL NO. STATOME 900Emc Industries1991-06-24
K901248ABC HANDPIECE ADAPTERBeacon Laboratories, Inc.1990-04-03
K881334LIGHT COAGULATOR LC 250Nk-Optik GmbH1989-11-16
K895337ELECTROSURGICAL COAGULATION SUCTION TUBENew England Surgical Instrument Corp.1989-09-15
K894663BEAMER ONEBeacon Laboratories, Inc.1989-09-15
K894762B100 DISPOSABLE HANDPIECEBeacon Laboratories, Inc.1989-09-15
K884171#875 DISPOSABLE BIOPOLAR CABLEOlsen Electrosurgical, Inc.1988-10-24
K884172MODIFIED OLSEN #770 DISPOSABLE HOLSTEROlsen Electrosurgical, Inc.1988-10-24
K884173#920 DISPOSABLE TUR CABLEOlsen Electrosurgical, Inc.1988-10-24
K884174MODIFIED OLSEN 755/756 SWITCHPENSOlsen Electrosurgical, Inc.1988-10-24

Legacy Summary#

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FDA Review#

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