510(k) K070293

Device
BENVENUE VCF OSTEO COIL SYSTEM
Applicant
BENVENUE MEDICAL, INC.
510(k) number
K070293
Product code
OCJ  
Decision
Substantially Equivalent (SESE)
Decision date
2007-07-10
Date received
2007-01-31
Regulation
888.4540
Classification name
Spinal Channeling Instrument, Vertebroplasty
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LAURENT SCHALLER
Address
1235 Pear Ave., #111 Mountain View CA US 94043 94043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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