510(k) K030576

ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II by The Anspach Effort, Inc. — Product Code FRN

K030576 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II". The FDA issued a decision of Substantially Equivalent on May 21, 2003. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2003
Date Received
February 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type