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510(k) K011789

PROCEDURE MASKS: PM4-301 AND PM4-304 by Primeline Medical Products, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2001
Date Received
June 8, 2001
Clearance Type
Special
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)
  • K001951 — PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCED (September 8, 2000)
  • K971076 — PRIMED SHOE COVERS, PRIMED HEAD COVERS (January 13, 1998)
  • K971075 — PRIMED PRIME-PLUS COTTON GAUZE SPONGES (June 22, 1997)

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