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510(k) K023540

SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 by Valumed — Product Code MMP

K023540 is an FDA 510(k) premarket notification submitted by Valumed for the device "SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09". The FDA issued a decision of Substantially Equivalent on February 4, 2003. The device falls under product code MMP (Cover, Barrier, Protective), a Class II device regulated under 21 CFR 878.4370. Valumed has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2003
Date Received
October 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Barrier, Protective
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Valumed

  • K023539 — STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSF (December 17, 2002)

Other clearances for product code MMP

  • K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (July 31, 2009)
  • K043234 — LIGHT DRAPE (May 25, 2005)
  • K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (November 30, 2004)
  • K040794 — INCUBATOR CAPE (June 10, 2004)
  • K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERS (September 22, 2003)
  • K014239 — MEDSURG EQUIPMENT COVERS (February 19, 2002)
  • K970885 — ULTRASOUND SYSTEMS DRAPE (September 22, 1997)
  • K962288 — COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (January 30, 1997)
  • K961699 — EQUIPMENT COVERS (August 23, 1996)
  • K952241 — PROTOUCH OVERGLOVE (August 7, 1995)

FDA data resources