510(k) K875287

H-H FLUSHING RESERVOIR by Holter-Hausner Intl. — Product Code JXG

K875287 is an FDA 510(k) premarket notification submitted by Holter-Hausner Intl. for the device "H-H FLUSHING RESERVOIR". The FDA issued a decision of Substantially Equivalent on July 14, 1988. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Holter-Hausner Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1988
Date Received
December 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