510(k) K062413

Device: AESCULAP PNEUMATIC KERRISON
Applicant: AESCULAP, INC.
510(k) number: K062413
Product code: HAD
Decision: Substantially Equivalent (SESE)
Decision date: 2006-11-21
Date received: 2006-08-17
Regulation: 882.4845
Classification name: Rongeur, Powered
Medical specialty: Neurology
Review panel: Neurology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: KATHY A RACOSKY
Address: 3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers#

2916714
9610612
3008711893

Source Documents#

Other 510(k) Records For Product Code HAD #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K022907	ANSPACH POWERED KERRISON SYSTEM (PKS)	The Anspach Effort, Inc.	2002-10-21
K911637	STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD	Personal Products Co.	1991-08-02

Legacy Summary#

summary

FDA Review#

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