510(k) K060933

SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM by Apex Medical Technologies, Inc. — Product Code MEB

K060933 is an FDA 510(k) premarket notification submitted by Apex Medical Technologies, Inc. for the device "SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 2006. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Apex Medical Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2006
Date Received
April 5, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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