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510(k) K880381

TELOS DISTAL TARGETING DEVICE by Austin Assoc. — Product Code HXY

K880381 is an FDA 510(k) premarket notification submitted by Austin Assoc. for the device "TELOS DISTAL TARGETING DEVICE". The FDA issued a decision of Substantially Equivalent on March 15, 1988. The device falls under product code HXY (Brace, Drill), a Class I device regulated under 21 CFR 888.4540.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 15, 1988
Date Received: January 27, 1988
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Brace, Drill
Device Class: Class I
Regulation Number: 888.4540
Review Panel: OR
Submission Type