CSF-VENTRICULAR CATHETER, STANDARD DES

Shunt, Central Nervous System And Components

PUDENZ-SCHULTE MEDICAL RESEARCH CORP.

The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Csf-ventricular Catheter, Standard Des.

Pre-market Notification Details

• Device ID: K792007
• 510k Number: K792007
• Device Name: CSF-VENTRICULAR CATHETER, STANDARD DES
• Classification: Shunt, Central Nervous System And Components
• Applicant: PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-10-05
• Decision Date: 1980-01-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169472600	K792007	000
00673978246246	K792007	000
00673978239309	K792007	000
00673978239293	K792007	000
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00613994965868	K792007	000
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00643169483132	K792007	000
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00643169482951	K792007	000
00643169472921	K792007	000
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00643169472846	K792007	000