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SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER - 350-300 S

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022099

by Hdc Corp.

Identifiers

510(k) Number
K022099 FDA 510(k)
FDA Product Code
FOZ FDA 510(k)
Models / Variants
350-300 S FDA 510(k)
360-300's FDA 510(k)
380-300's FDA 510(k)
390-300's FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER - 350-300 S by Hdc Corp. — Class II — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hdc Corp.

Sources (1)

  • FDA 510(k) K022099 24 fields · synced Jun 18, 2026