510(k) K932769

CAMINO VENTRICULAR DRAINAGE SYSTEM by Camino Laboratories, Inc. — Product Code JXG

K932769 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "CAMINO VENTRICULAR DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 30, 1995. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Camino Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1995
Date Received
June 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type