WAYPOINT STEREOTACTIC SYSTEM

Neurological Stereotaxic Instrument

FHC, INC.

The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Waypoint Stereotactic System.

Pre-market Notification Details

• Device ID: K092192
• 510k Number: K092192
• Device Name: WAYPOINT STEREOTACTIC SYSTEM
• Classification: Neurological Stereotaxic Instrument
• Applicant: FHC, INC. 1201 MAIN ST Bowdoin, ME 04287
• Contact: Lee D Margolin
• Correspondent: Lee D Margolin; FHC, INC. 1201 MAIN ST Bowdoin, ME 04287
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-21
• Decision Date: 2010-02-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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