SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8

Shunt, Central Nervous System And Components

SOPHYSA SA

The following data is part of a premarket notification filed by Sophysa Sa with the FDA for Sophy Pressure Adjustable Valve System Model Sm8.

Pre-market Notification Details

• Device ID: K013488
• 510k Number: K013488
• Device Name: SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
• Classification: Shunt, Central Nervous System And Components
• Applicant: SOPHYSA SA 70 WALNUT ST. Wellesley, MA 02481
• Contact: Jacqueline E Masse
• Correspondent: Jacqueline E Masse; SOPHYSA SA 70 WALNUT ST. Wellesley, MA 02481
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-10-19
• Decision Date: 2002-03-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03760124130034	K013488	000
13760124130161	K013488	000
13760124130154	K013488	000
03760124130669	K013488	000
03760124130652	K013488	000
03760124130645	K013488	000
03760124130638	K013488	000
03760124130621	K013488	000
03760124130614	K013488	000
03760124130607	K013488	000
03760124130591	K013488	000
03760124130584	K013488	000
03760124130171	K013488	000
03760124131093	K013488	000
03760124131116	K013488	000
03760124130027	K013488	000
03760124130010	K013488	000
03760124131246	K013488	000
03760124131239	K013488	000
03760124131222	K013488	000
03760124131215	K013488	000
03760124131161	K013488	000
03760124131154	K013488	000
03760124131147	K013488	000
03760124131130	K013488	000
03760124131123	K013488	000
03760124130577	K013488	000