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510(k) K050575

FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM by Futumeds Sdn Bhd — Product Code MDM

K050575 is an FDA 510(k) premarket notification submitted by Futumeds Sdn Bhd for the device "FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM". The FDA issued a decision of Substantially Equivalent on August 15, 2005. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2005
Date Received
March 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Surgical, General Use
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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FDA data resources