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FDA 510(k)

STERITEC DRY HEAT INDICATOR LABEL

K-Number: K953122 · 1997-04-02

ApplicantSteritec Products Mfg Co, Inc.
Decision Date1997-04-02
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERITEC DRY HEAT INDICATOR LABEL is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products Mfg Co, Inc.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K953122. 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 STERITEC DRY HEAT INDICATOR LABEL?

STERITEC DRY HEAT INDICATOR LABEL is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Steritec Products Mfg Co, Inc.. The 510(k) number is K953122.

When did STERITEC DRY HEAT INDICATOR LABEL receive FDA 510(k) clearance?

STERITEC DRY HEAT INDICATOR LABEL received FDA 510(k) clearance on 1997-04-02, under 510(k) number K953122.

Who is the listed applicant for STERITEC DRY HEAT INDICATOR LABEL?

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

What is the FDA product code for STERITEC DRY HEAT INDICATOR LABEL?

The FDA product code for STERITEC DRY HEAT INDICATOR LABEL is JOJ.

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Other records listing Steritec Products Mfg Co, Inc. as applicant

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K200252Getinge Assured MI Steam Migrating IntegratorK132372STERITEC GREEN CARD PACK BOWIE-DICK TESTK122945STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126K122555STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPEK111150STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATORK103000SMART READ BIOLOGICAL 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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