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FDA 510(k)

MEDICOM SELF-SEALING STERILIZATION POUCH

K-Number: K070428 · 2007-07-17

ApplicantA.R. Medicom, Inc.
Decision Date2007-07-17
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDICOM SELF-SEALING STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is A.R. Medicom, Inc.. It received FDA 510(k) clearance on 2007-07-17 under 510(k) number K070428. 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 MEDICOM SELF-SEALING STERILIZATION POUCH?

MEDICOM SELF-SEALING STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 2007-07-17. The listed applicant is A.R. Medicom, Inc.. The 510(k) number is K070428.

When did MEDICOM SELF-SEALING STERILIZATION POUCH receive FDA 510(k) clearance?

MEDICOM SELF-SEALING STERILIZATION POUCH received FDA 510(k) clearance on 2007-07-17, under 510(k) number K070428.

Who is the listed applicant for MEDICOM SELF-SEALING STERILIZATION POUCH?

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

What is the FDA product code for MEDICOM SELF-SEALING STERILIZATION POUCH?

The FDA product code for MEDICOM SELF-SEALING STERILIZATION POUCH is KCT.

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 A.R. Medicom, 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.

K051291NON-STERILE SURGICAL MASKK935257MEDICOM NON-WOVEN SPONGES

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

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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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