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510(k) K935220

CORE PREVENT MATTRESS MODIFICATION by Paladin Medical, Inc. — Product Code FMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1993
Date Received
October 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Mattress (Medical Purposes)
Device Class
Class I
Regulation Number
880.6190
Review Panel
HO
Submission Type

Other clearances by Paladin Medical, Inc.

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  • K970347 — MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM (August 29, 1997)
  • K971290 — STRATASYS FDM MEDMODELER SYSTEM (June 20, 1997)
  • K964222 — ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (December 20, 1996)
  • K950054 — ENDO-BEND(TM) SHAVER (June 29, 1995)
  • K921015 — SHARPE ENDOSPONGE ASPIIRATOR (May 21, 1993)
  • K915743 — SHARPE ENDOTENACULUM (May 20, 1993)
  • K921888 — SHARPE ENDODISSECTOR (October 20, 1992)
  • K915749 — SHARPE ENDOLIGATURE CARRIER (October 20, 1992)
  • K915744 — SHARPE ENDOHEMOSTAT (October 20, 1992)

Other clearances for product code FMW

  • K152884 — DermaTherapy Bed Linens (June 20, 2016)
  • K061242 — DERMATHERAPY, MODEL 22216 (January 25, 2007)
  • K001003 — Z-NET (December 10, 2001)
  • K992702 — EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PI (November 8, 1999)
  • K940327 — INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MAT (February 25, 1994)
  • K924807 — REUSABLE INCONTIENT UNDERPAD (February 10, 1993)
  • K924477 — WIPEABLE PILLOW (January 29, 1993)
  • K921928 — SOFT-COVER (November 6, 1992)
  • K923173 — OBALON COVER (November 6, 1992)
  • K903382 — ALLERGY CONTROL COVERS (November 2, 1990)