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FDA 510(k)

STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE

K-Number: K894398 · 1989-09-11

ApplicantPymah Corp.
Decision Date1989-09-11
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE is the device name listed in this FDA 510(k) record. The listed applicant is Pymah Corp.. It received FDA 510(k) clearance on 1989-09-11 under 510(k) number K894398. 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 STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE?

STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE is a medical device that received FDA 510(k) clearance on 1989-09-11. The listed applicant is Pymah Corp.. The 510(k) number is K894398.

When did STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE receive FDA 510(k) clearance?

STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE received FDA 510(k) clearance on 1989-09-11, under 510(k) number K894398.

Who is the listed applicant for STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE?

The FDA 510(k) record lists Pymah Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE?

The FDA product code for STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE is FRC.

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Other records listing Pymah Corp. 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.

K952995ATI ETHYLENE OXIDE STERILIZATION INDICATORK952408ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATIONK951063ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATIONK934874STERIGAGE EO 100%K943081TRIMLINE 2000K925496ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK

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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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