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510(k) K001951

PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 by Primeline Medical Products, Inc. — Product Code FXX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 8, 2000
Date Received: June 27, 2000
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

Other clearances by Primeline Medical Products, Inc.

K022868 — PRIMAGARD SURGICAL EQUIPMENT DRAPES (November 8, 2002)
K023266 — PRIMAGARD SURGICAL GOWNS (November 8, 2002)
K023117 — PRIMAGARD SURGICAL GOWNS (November 8, 2002)
K021864 — PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1- (September 23, 2002)
K021076 — PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGI (April 16, 2002)
K011789 — PROCEDURE MASKS: PM4-301 AND PM4-304 (June 22, 2001)
K971076 — PRIMED SHOE COVERS, PRIMED HEAD COVERS (January 13, 1998)
K971075 — PRIMED PRIME-PLUS COTTON GAUZE SPONGES (June 22, 1997)

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