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510(k) K933527

Device
MODIFICATION OF ANTERIOR SEGMENT ELECTRODES
Applicant
MIRA, INC.
510(k) number
K933527
Product code
HWA  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-25
Date received
1993-07-20
Regulation
888.4540
Classification name
Impactor
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROGER R O'BRIEN
Address
87 Rumford Ave. Waltham MA US 02453 02453

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HWA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K864422RAYLOR(TM) MALLETCedar Surgical, Inc.1986-11-24
K841627MALLETPlastafil, Inc.1984-08-27
K770205CEMENT CHISELSDepuy, Inc.1977-02-08

Legacy Summary#

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FDA Review#

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