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FDA 510(k)

DANA REUSABLE TEST PACK FOR STEAM STERILIZATION

K-Number: K092944 · 2010-03-18

ApplicantDana Products, Inc.
Decision Date2010-03-18
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DANA REUSABLE TEST PACK FOR STEAM STERILIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Dana Products, Inc.. It received FDA 510(k) clearance on 2010-03-18 under 510(k) number K092944. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANA REUSABLE TEST PACK FOR STEAM STERILIZATION?

DANA REUSABLE TEST PACK FOR STEAM STERILIZATION is a medical device that received FDA 510(k) clearance on 2010-03-18. The listed applicant is Dana Products, Inc.. The 510(k) number is K092944.

When did DANA REUSABLE TEST PACK FOR STEAM STERILIZATION receive FDA 510(k) clearance?

DANA REUSABLE TEST PACK FOR STEAM STERILIZATION received FDA 510(k) clearance on 2010-03-18, under 510(k) number K092944.

Who is the listed applicant for DANA REUSABLE TEST PACK FOR STEAM STERILIZATION?

The FDA 510(k) record lists Dana Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DANA REUSABLE TEST PACK FOR STEAM STERILIZATION?

The FDA product code for DANA REUSABLE TEST PACK FOR STEAM STERILIZATION is FRC.

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Other records listing Dana Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130135DANA REUSABLE BI TEST PACKK120592DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORSK110253REUSABLE TEST PACK FOR DANA EMULATING INDICATORSK103321DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLESK100891DANA EMULATING INDICATORK102761DANA REUSABLE TEST PACK FOR STEAM STERILIZATION

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Related Devices (Code: FRC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS CorporationK250061Celerity IncubatorSTERIS Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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