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510(k) K942823

Device
MAHE INSTRUMENTS
Applicant
MAHE INTL., INC.
510(k) number
K942823
Product code
DWG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-05
Date received
1994-06-14
Regulation
878.4400
Classification name
Electrosurgical Device
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
WINFRIED REICH
Address
300 James Robertson Pkwy. Nashville TN US 37201 37201

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DWG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932345TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USEConmedcorp1994-04-12
K931215HAND-TROL SAspen Labs1994-03-28
K925708DISPOSABLE ELECTROSURGERY BALL ELECTRODEBeacon Laboratories, Inc.1993-04-20

Legacy Summary#

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FDA Review#

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