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510(k) K924807

REUSABLE INCONTIENT UNDERPAD by Perfect Fit Industries, Inc. — Product Code FMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1993
Date Received
September 3, 1992
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 Perfect Fit Industries, Inc.

  • K924477 — WIPEABLE PILLOW (January 29, 1993)

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  • K940327 — INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MAT (February 25, 1994)
  • K935220 — CORE PREVENT MATTRESS MODIFICATION (November 29, 1993)
  • K924477 — WIPEABLE PILLOW (January 29, 1993)
  • K923173 — OBALON COVER (November 6, 1992)
  • K921928 — SOFT-COVER (November 6, 1992)
  • K903382 — ALLERGY CONTROL COVERS (November 2, 1990)