510(k) K770205

Device: CEMENT CHISELS
Applicant: Depuy, Inc.
510(k) number: K770205
Product code: HWA
Decision: Substantially Equivalent (SESE)
Decision date: 1977-02-08
Date received: 1977-01-31
Regulation: 888.4540
Classification name: Impactor
Medical specialty: Orthopedic
Review panel: Orthopedic
Device class: 1
Clearance type: Traditional
Third party reviewed: N

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)	Device	Applicant	Decision date
K933527	MODIFICATION OF ANTERIOR SEGMENT ELECTRODES	Mira, Inc.	1994-01-25
K864422	RAYLOR(TM) MALLET	Cedar Surgical, Inc.	1986-11-24
K841627	MALLET	Plastafil, Inc.	1984-08-27