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510(k) K923776

Device
Benderev Drill Guide
Applicant
NEIMARK LABS, INC.
510(k) number
K923776
Product code
HXY
Decision
Substantially Equivalent (SESE)
Decision date
1992-11-06
Date received
1992-07-28
Regulation
888.4540
Classification name
Brace, Drill
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
NEIL H NAVES
Address
26732 Crown Valley, 501 Mission Viejo CA US 92691 92691

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K892904MITEK DRILL GUIDEMitek Surgical Products, Inc.1989-09-28
K880264BONE SUTURE FIXATION DEVICEOrthopedic Systems, Inc.1988-03-23
K880381TELOS DISTAL TARGETING DEVICEAustin Assoc.1988-03-15
K880046HASTING FINGER FIXATOR INSTRUMENTSBuckman Co., Inc.1988-02-16
K831043ANDREWS REMOTE CHUCK DRILLOrthopedic Systems, Inc.1983-04-28
K770204CEMENT EXTRACTOR DRILLDepuy, Inc.1977-02-08