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Neomed Sterile Syringe (Sd-S1eo +6 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K092908

by Neomed, Inc.

Identifiers

510(k) Number
K092908 FDA 510(k)
FDA Product Code
FMF FDA 510(k)
Models / Variants
Sd-S1eo FDA 510(k)
Sd-S3eo FDA 510(k)
Sd-S630 FDA 510(k)
Sd-S12eo FDA 510(k)
Sd-S20eo FDA 510(k)
Sd-S35eo FDA 510(k)
Sd-S60eo FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Neomed Sterile Syringe (Sd-S1eo +6 more) by Neomed, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 7 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Neomed, Inc.

Sources (1)

  • FDA 510(k) K092908 24 fields · synced Jun 18, 2026