510(k) K871685

HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS by American V. Mueller — Product Code JXG

K871685 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS". The FDA issued a decision of Substantially Equivalent on June 12, 1987. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. American V. Mueller has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1987
Date Received
April 29, 1987
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