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FDA 510(k)

STERILIZATION INDICATOR/SEAL PROTECTOR

K-Number: K811408 · 1981-06-12

ApplicantBeacon Converters, Inc.
Decision Date1981-06-12
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILIZATION INDICATOR/SEAL PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Beacon Converters, Inc.. It received FDA 510(k) clearance on 1981-06-12 under 510(k) number K811408. 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 STERILIZATION INDICATOR/SEAL PROTECTOR?

STERILIZATION INDICATOR/SEAL PROTECTOR is a medical device that received FDA 510(k) clearance on 1981-06-12. The listed applicant is Beacon Converters, Inc.. The 510(k) number is K811408.

When did STERILIZATION INDICATOR/SEAL PROTECTOR receive FDA 510(k) clearance?

STERILIZATION INDICATOR/SEAL PROTECTOR received FDA 510(k) clearance on 1981-06-12, under 510(k) number K811408.

Who is the listed applicant for STERILIZATION INDICATOR/SEAL PROTECTOR?

The FDA 510(k) record lists Beacon Converters, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILIZATION INDICATOR/SEAL PROTECTOR?

The FDA product code for STERILIZATION INDICATOR/SEAL PROTECTOR is JOJ.

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Other records listing Beacon Converters, 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.

K810469STERILEDGE SELF SEAL POUCH

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

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