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510(k) K980224

Device
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822
Applicant
ALEXANDER MFG. CO.
510(k) number
K980224
Product code
MOQ  
Decision
Substantially Equivalent (SESE)
Decision date
1998-04-02
Date received
1998-01-22
Regulation
878.4820
Classification name
Battery, Replacement, Rechargeable
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KEN HEIMENDINGER
Address
1511 S Garfield Pl. Mason City IA US 50401 50401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MOQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081713VERTEBRAL ACCESS SYSTEM BY VIDACAREVidacare Corporation2008-11-21
K013133NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116Nordix, Inc.2001-11-13

Legacy Summary#

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FDA Review#

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