510(k) K081713

Device
VERTEBRAL ACCESS SYSTEM BY VIDACARE
Applicant
VIDACARE CORPORATION
510(k) number
K081713
Product code
MOQ  
Decision
Substantially Equivalent (SESE)
Decision date
2008-11-21
Date received
2008-06-17
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
GRACE HOLLAND
Address
3722 Ave. Sausalito Irvine CA US 92606 92606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MOQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K013133NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116Nordix, Inc.2001-11-13
K980224ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS822Alexander Mfg. Co.1998-04-02

Legacy Summary#

summary

FDA Review#

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