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510(k) K903382

ALLERGY CONTROL COVERS by Allergy Control Products, Inc. — Product Code FMW

K903382 is an FDA 510(k) premarket notification submitted by Allergy Control Products, Inc. for the device "ALLERGY CONTROL COVERS". The FDA issued a decision of Substantially Equivalent on November 2, 1990. The device falls under product code FMW (Cover, Mattress (Medical Purposes)), a Class I device regulated under 21 CFR 880.6190.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1990
Date Received
July 27, 1990
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 for product code FMW

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  • 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)
  • K935220 — CORE PREVENT MATTRESS MODIFICATION (November 29, 1993)
  • K924807 — REUSABLE INCONTIENT UNDERPAD (February 10, 1993)
  • K924477 — WIPEABLE PILLOW (January 29, 1993)
  • K923173 — OBALON COVER (November 6, 1992)
  • K921928 — SOFT-COVER (November 6, 1992)

FDA data resources