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FDA 510(k)

STERILEDGE SELF SEAL POUCH

K-Number: K810469 · 1981-06-01

ApplicantBeacon Converters, Inc.
Decision Date1981-06-01
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILEDGE SELF SEAL POUCH 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 1981-06-01 under 510(k) number K810469. 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 STERILEDGE SELF SEAL POUCH?

STERILEDGE SELF SEAL POUCH is a medical device that received FDA 510(k) clearance on 1981-06-01. The listed applicant is Beacon Converters, Inc.. The 510(k) number is K810469.

When did STERILEDGE SELF SEAL POUCH receive FDA 510(k) clearance?

STERILEDGE SELF SEAL POUCH received FDA 510(k) clearance on 1981-06-01, under 510(k) number K810469.

Who is the listed applicant for STERILEDGE SELF SEAL POUCH?

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 STERILEDGE SELF SEAL POUCH?

The FDA product code for STERILEDGE SELF SEAL POUCH is KCT.

Related Clinical Trials

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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.

K811408STERILIZATION INDICATOR/SEAL PROTECTOR

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 SurgicalK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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