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510(k) K960641

RECAP-1 by Medscience, Inc. — Product Code FMI

K960641 is an FDA 510(k) premarket notification submitted by Medscience, Inc. for the device "RECAP-1". The FDA issued a decision of Substantially Equivalent on May 17, 1996. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1996
Date Received
February 14, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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FDA data resources