510(k) K071776

Device: ANEUROPLASTIC, MODEL 43-1290
Applicant: Codman & Shurtleff, Inc.
510(k) number: K071776
Product code: JXH
Decision: Substantially Equivalent (SESE)
Decision date: 2007-07-26
Date received: 2007-06-29
Regulation: 882.5030
Classification name: Methyl Methacrylate For Aneurysmorrhaphy
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: RACHEL CREME
Address: 325 Paramount Dr. Raynham MA US 02767 02767

FDA Registration Numbers#

3008132398
9610921

Source Documents#

Other 510(k) Records For Product Code JXH #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K882072	ORTHOPAEDIC AND SPINAL RING CURRETTES	Karlin Technology, Inc.	1988-06-17
K873688	ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL	Dentsply Intl.	1987-10-26

Legacy Summary#

summary

FDA Review#

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