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510(k) K841627

Device
MALLET
Applicant
PLASTAFIL, INC.
510(k) number
K841627
Product code
HWA  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-27
Date received
1984-04-19
Regulation
888.4540
Classification name
Impactor
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K864422RAYLOR(TM) MALLETCedar Surgical, Inc.1986-11-24
K770205CEMENT CHISELSDepuy, Inc.1977-02-08

Legacy Summary#

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FDA Review#

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