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510(k) K022868

PRIMAGARD SURGICAL EQUIPMENT DRAPES by Primeline Medical Products, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2002
Date Received
August 29, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Primeline Medical Products, Inc.

  • 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)
  • 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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  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)