FDA 510(k)

DOWN PAK

K-Number: K070246 · 2007-02-16

Decision Date2007-02-16

Product CodeEKM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DOWN PAK is the device name listed in this FDA 510(k) record. The listed applicant is Endo Twinn B.V.. It received FDA 510(k) clearance on 2007-02-16 under 510(k) number K070246. 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 DOWN PAK?

DOWN PAK is a medical device that received FDA 510(k) clearance on 2007-02-16. The listed applicant is Endo Twinn B.V.. The 510(k) number is K070246.

When did DOWN PAK receive FDA 510(k) clearance?

DOWN PAK received FDA 510(k) clearance on 2007-02-16, under 510(k) number K070246.

Who is the listed applicant for DOWN PAK?

The FDA 510(k) record lists Endo Twinn B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOWN PAK?

The FDA product code for DOWN PAK is EKM.

Other records listing Endo Twinn B.V. 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.

K042870ENDO TWINN

Related Devices (Code: EKM)

K073369EI DOWNPAK BARRIER SLEEVESHu-Friedy Mfg. Co., Inc.K051573TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)Dr. Howard Martin, P.A.K042870ENDO TWINNEndo Twinn B.V.K023819FIBERFILL SGPPentron Clinical Technologies K971641ANTIBACTERIAL GUTTA PERCHADr. Howard Martin, P.A.K970134THERMAPREP PLUS OVENTulsa Dental Products, Ltd.

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.