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510(k) K940907

MADDEN SURGICAL THIMBLE by Kelley-Gilmer Medical Corp. — Product Code KNA

K940907 is an FDA 510(k) premarket notification submitted by Kelley-Gilmer Medical Corp. for the device "MADDEN SURGICAL THIMBLE". The FDA issued a decision of Substantially Equivalent on December 29, 1994. The device falls under product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1994
Date Received
February 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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FDA data resources