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FDA 510(k)

EI DOWNPAK BARRIER SLEEVES

K-Number: K073369 · 2008-02-27

ApplicantHu-Friedy Mfg. Co., Inc.
Decision Date2008-02-27
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EI DOWNPAK BARRIER SLEEVES is the device name listed in this FDA 510(k) record. The listed applicant is Hu-Friedy Mfg. Co., Inc.. It received FDA 510(k) clearance on 2008-02-27 under 510(k) number K073369. The device is classified under product code EKM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EI DOWNPAK BARRIER SLEEVES?

EI DOWNPAK BARRIER SLEEVES is a medical device that received FDA 510(k) clearance on 2008-02-27. The listed applicant is Hu-Friedy Mfg. Co., Inc.. The 510(k) number is K073369.

When did EI DOWNPAK BARRIER SLEEVES receive FDA 510(k) clearance?

EI DOWNPAK BARRIER SLEEVES received FDA 510(k) clearance on 2008-02-27, under 510(k) number K073369.

Who is the listed applicant for EI DOWNPAK BARRIER SLEEVES?

The FDA 510(k) record lists Hu-Friedy Mfg. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EI DOWNPAK BARRIER SLEEVES?

The FDA product code for EI DOWNPAK BARRIER SLEEVES is EKM.

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Other records listing Hu-Friedy Mfg. Co., Inc. as applicant

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Related Devices (Code: EKM)

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.

K070246DOWN PAKEndo Twinn B.V.K051573TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)Dr. Howard Martin, P.A.K042870ENDO TWINNEndo Twinn B.V.K023819FIBERFILL SGPPentron Clinical TechnologiesK971641ANTIBACTERIAL GUTTA PERCHADr. Howard Martin, P.A.K970134THERMAPREP PLUS OVENTulsa Dental Products, Ltd.

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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