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510(k) K070407

DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE by Dukal Corp. — Product Code FXX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 26, 2007
Date Received: February 12, 2007
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mask, Surgical
Device Class: Class II
Regulation Number: 878.4040
Review Panel: HO
Submission Type

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K955476 — DUKAL TRANSPARENT WOUND DRESSING (January 18, 1996)
K940440 — DUKAL NON-WOVEN GAUZE (March 9, 1994)
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