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Freeze Point & Private Label Versions

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242625

by Cryoconcepts, Lp

Identifiers

510(k) Number
K242625 FDA 510(k)
FDA Product Code
GEH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4350 FDA 510(k)
Regulation Number
878.4350 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Freeze Point & Private Label Versions by Cryoconcepts, Lp — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cryoconcepts, Lp
FDA Applicant
Cryoconcepts LP

Sources (1)

  • FDA 510(k) K242625 24 fields · synced Jun 18, 2026