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FDA 510(k)

DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES

K-Number: K103321 · 2011-02-16

ApplicantDana Products, Inc.
Decision Date2011-02-16
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES 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 2011-02-16 under 510(k) number K103321. 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 TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES?

DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES is a medical device that received FDA 510(k) clearance on 2011-02-16. The listed applicant is Dana Products, Inc.. The 510(k) number is K103321.

When did DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES receive FDA 510(k) clearance?

DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES received FDA 510(k) clearance on 2011-02-16, under 510(k) number K103321.

Who is the listed applicant for DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES?

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 TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES?

The FDA product code for DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES 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 INDICATORSK100891DANA EMULATING INDICATORK102761DANA REUSABLE TEST PACK FOR STEAM STERILIZATIONK092944DANA 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)SterisK250061Celerity IncubatorSTERIS CorporationK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS 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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