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FDA 510(k)

STERRAD STERILIZATION POUCH

K-Number: K951295 · 1995-05-19

ApplicantAdvanced Sterilization Products
Decision Date1995-05-19
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 1995-05-19 under 510(k) number K951295. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERRAD STERILIZATION POUCH?

STERRAD STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 1995-05-19. The listed applicant is Advanced Sterilization Products. The 510(k) number is K951295.

When did STERRAD STERILIZATION POUCH receive FDA 510(k) clearance?

STERRAD STERILIZATION POUCH received FDA 510(k) clearance on 1995-05-19, under 510(k) number K951295.

Who is the listed applicant for STERRAD STERILIZATION POUCH?

The FDA 510(k) record lists Advanced Sterilization Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERRAD STERILIZATION POUCH?

The FDA product code for STERRAD STERILIZATION POUCH is KCT.

Related Clinical Trials

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Other records listing Advanced Sterilization Products 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.

K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical IndicatorK162007STERRAD NX SterilizerK160818STERRAD® NX Sterilizer with ALLClear™ TechnologyK160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyK151725STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

View all 49 devices →

Related Devices (Code: KCT)

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, 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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