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Standard Supreme Sterilization Wrapper

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172207

by Standard Textile Co., Inc.

Identifiers

510(k) Number
K172207 FDA 510(k)
FDA Product Code
FRG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Standard Supreme Sterilization Wrapper by Standard Textile Co., Inc. — 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

Sources (1)

  • FDA 510(k) K172207 24 fields · synced Jun 18, 2026