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510(k) K780033

MATTRESSES, CONDUCTIVE & COVERS by Chase Mfg. Co. — Product Code FMW

K780033 is an FDA 510(k) premarket notification submitted by Chase Mfg. Co. for the device "MATTRESSES, CONDUCTIVE & COVERS". The FDA issued a decision of Substantially Equivalent on February 21, 1978. The device falls under product code FMW (Cover, Mattress (Medical Purposes)), a Class I device regulated under 21 CFR 880.6190. Chase Mfg. Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1978
Date Received
January 9, 1978
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 Chase Mfg. Co.

  • K791513 — ADAMCO DUST COVER (October 11, 1979)
  • K790993 — INSTANT HOT & COLD PACKS (September 7, 1979)
  • K790644 — SUBMAX (April 26, 1979)
  • K771792 — ENEMA SET (October 20, 1977)
  • K771791 — NEEDLE COUNTING (October 4, 1977)
  • K770900 — CAST BRWM, FRACTURE (July 21, 1977)
  • K770898 — FRACTURE CAST BRACE KIT, PLASTIC (July 21, 1977)
  • K770899 — FRACTURE CAST BRACE, POLY (July 21, 1977)
  • K770173 — STOCKINETTE (February 8, 1977)

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)
  • K935220 — CORE PREVENT MATTRESS MODIFICATION (November 29, 1993)
  • 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)

FDA data resources