HEMORX COLD PACK— 510(k) K883984

Substantially Equivalent

Bio-Dyne, Inc.

FDA 510(k) clearance K883984 for HEMORX COLD PACK, Substantially Equivalent on 1988-12-22. Applicant: Bio-Dyne, Inc.. Device class: Unclassified.

Clearance details

Applicant: Bio-Dyne, Inc.
Product code: Code LKX
Device class: Unclassified
Advisory panel: Unknown
Date received: 1988-09-20
Decision date: 1988-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKX

K172358 — Instalief2018-01-10
K113660 — COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL2012-05-03
K072414 — CRYOSTAT2008-04-07
K042564 — HEMOR-RITE CRYOTHERAPHY2005-09-30
K012746 — ICE BATON2001-11-14

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Data sourced from openFDA. This site is unofficial and independent of the FDA.