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FDA 510(k)

ATI ETHYLENE OXIDE STERILIZATION INDICATOR

K-Number: K952995 · 1996-02-22

ApplicantPymah Corp.
Decision Date1996-02-22
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ATI ETHYLENE OXIDE STERILIZATION INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Pymah Corp.. It received FDA 510(k) clearance on 1996-02-22 under 510(k) number K952995. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATI ETHYLENE OXIDE STERILIZATION INDICATOR?

ATI ETHYLENE OXIDE STERILIZATION INDICATOR is a medical device that received FDA 510(k) clearance on 1996-02-22. The listed applicant is Pymah Corp.. The 510(k) number is K952995.

When did ATI ETHYLENE OXIDE STERILIZATION INDICATOR receive FDA 510(k) clearance?

ATI ETHYLENE OXIDE STERILIZATION INDICATOR received FDA 510(k) clearance on 1996-02-22, under 510(k) number K952995.

Who is the listed applicant for ATI ETHYLENE OXIDE STERILIZATION INDICATOR?

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 ATI ETHYLENE OXIDE STERILIZATION INDICATOR?

The FDA product code for ATI ETHYLENE OXIDE STERILIZATION INDICATOR is JOJ.

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Other records listing Pymah Corp. as applicant

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K952408ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATIONK951063ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATIONK934874STERIGAGE EO 100%K943081TRIMLINE 2000K925496ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACKK925745ATI(R) DISP BIOLOGICAL-PLUS TEST PACK

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Related Devices (Code: JOJ)

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K2619923M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLCK260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS 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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