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510(k) K864422

Device
RAYLOR(TM) MALLET
Applicant
CEDAR SURGICAL, INC.
510(k) number
K864422
Product code
HWA  
Decision
Substantially Equivalent (SESE)
Decision date
1986-11-24
Date received
1986-11-10
Regulation
888.4540
Classification name
Impactor
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TERRY P CORBIN
Address
15265 Minnetonka Blvd. Minnetonka MN US 55345 55345

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
K933527MODIFICATION OF ANTERIOR SEGMENT ELECTRODESMira, Inc.1994-01-25
K841627MALLETPlastafil, Inc.1984-08-27
K770205CEMENT CHISELSDepuy, Inc.1977-02-08

Legacy Summary#

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FDA Review#

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