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FDA 510(k)

STERI-DENT, STERI-SURE

K-Number: K110867 · 2011-07-20

ApplicantCpac, Inc.
Decision Date2011-07-20
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERI-DENT, STERI-SURE is the device name listed in this FDA 510(k) record. The listed applicant is Cpac, Inc.. It received FDA 510(k) clearance on 2011-07-20 under 510(k) number K110867. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERI-DENT, STERI-SURE?

STERI-DENT, STERI-SURE is a medical device that received FDA 510(k) clearance on 2011-07-20. The listed applicant is Cpac, Inc.. The 510(k) number is K110867.

When did STERI-DENT, STERI-SURE receive FDA 510(k) clearance?

STERI-DENT, STERI-SURE received FDA 510(k) clearance on 2011-07-20, under 510(k) number K110867.

Who is the listed applicant for STERI-DENT, STERI-SURE?

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

What is the FDA product code for STERI-DENT, STERI-SURE?

The FDA product code for STERI-DENT, STERI-SURE is FRG.

Related Clinical Trials

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.

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Other records listing Cpac, 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.

K094026STERI-DENT, STERI-SUREK781486STERI-VAC POWER UNITSK771071PORTO-VACK771070DRY HEAT STERILIZER

Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

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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