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FDA 510(k)

ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION

K-Number: K952408 · 1995-07-06

ApplicantPymah Corp.
Decision Date1995-07-06
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Pymah Corp.. It received FDA 510(k) clearance on 1995-07-06 under 510(k) number K952408. 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 DISPOSABLE TEST PACK FOR STEAM STERILIZATION?

ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION is a medical device that received FDA 510(k) clearance on 1995-07-06. The listed applicant is Pymah Corp.. The 510(k) number is K952408.

When did ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION receive FDA 510(k) clearance?

ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION received FDA 510(k) clearance on 1995-07-06, under 510(k) number K952408.

Who is the listed applicant for ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION?

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 DISPOSABLE TEST PACK FOR STEAM STERILIZATION?

The FDA product code for ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION is JOJ.

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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 INDICATORK951063ATI 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)

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.

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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