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510(k) K971277

SAFE-T-CLAMP by Talon Medical, Ltd. — Product Code KNA

K971277 is an FDA 510(k) premarket notification submitted by Talon Medical, Ltd. for the device "SAFE-T-CLAMP". The FDA issued a decision of Substantially Equivalent on May 20, 1997. 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
May 20, 1997
Date Received
April 7, 1997
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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  • K001590 — DND 101 (August 2, 2000)
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FDA data resources