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FDA 510(k)

MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH

K-Number: K993764 · 1999-12-16

ApplicantMedipack Medical Packaging Mfg. Co.
Decision Date1999-12-16
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Medipack Medical Packaging Mfg. Co.. It received FDA 510(k) clearance on 1999-12-16 under 510(k) number K993764. 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 MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH?

MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 1999-12-16. The listed applicant is Medipack Medical Packaging Mfg. Co.. The 510(k) number is K993764.

When did MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH receive FDA 510(k) clearance?

MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH received FDA 510(k) clearance on 1999-12-16, under 510(k) number K993764.

Who is the listed applicant for MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH?

The FDA 510(k) record lists Medipack Medical Packaging Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH?

The FDA product code for MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH is KCT.

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Other records listing Medipack Medical Packaging Mfg. Co. 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.

K034015EARLOOP PROCEDURE MASK

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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