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FDA 510(k)

HARKEN ASSURE SELF-SEAL STERILIZATION POUCH

K-Number: K945055 · 1994-12-14

ApplicantHarken Products, Inc.
Decision Date1994-12-14
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HARKEN ASSURE SELF-SEAL STERILIZATION POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Harken Products, Inc.. It received FDA 510(k) clearance on 1994-12-14 under 510(k) number K945055. 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 HARKEN ASSURE SELF-SEAL STERILIZATION POUCH?

HARKEN ASSURE SELF-SEAL STERILIZATION POUCH is a medical device that received FDA 510(k) clearance on 1994-12-14. The listed applicant is Harken Products, Inc.. The 510(k) number is K945055.

When did HARKEN ASSURE SELF-SEAL STERILIZATION POUCH receive FDA 510(k) clearance?

HARKEN ASSURE SELF-SEAL STERILIZATION POUCH received FDA 510(k) clearance on 1994-12-14, under 510(k) number K945055.

Who is the listed applicant for HARKEN ASSURE SELF-SEAL STERILIZATION POUCH?

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

What is the FDA product code for HARKEN ASSURE SELF-SEAL STERILIZATION POUCH?

The FDA product code for HARKEN ASSURE SELF-SEAL STERILIZATION POUCH is KCT.

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Related Devices (Code: KCT)

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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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