AMERICAN HEYER-SCHULTE LOW PROFILE VALVE

Shunt, Central Nervous System And Components

AMERICAN HEYER SCHULTE

The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for American Heyer-schulte Low Profile Valve.

Pre-market Notification Details

• Device ID: K802586
• 510k Number: K802586
• Device Name: AMERICAN HEYER-SCHULTE LOW PROFILE VALVE
• Classification: Shunt, Central Nervous System And Components
• Applicant: AMERICAN HEYER SCHULTE 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-10-20
• Decision Date: 1980-12-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382830057349	K802586	000