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FDA 510(k)

NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM

K-Number: K080275 · 2008-10-09

ApplicantIasis Medical, Inc.
Decision Date2008-10-09
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Iasis Medical, Inc.. It received FDA 510(k) clearance on 2008-10-09 under 510(k) number K080275. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM?

NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-09. The listed applicant is Iasis Medical, Inc.. The 510(k) number is K080275.

When did NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM receive FDA 510(k) clearance?

NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM received FDA 510(k) clearance on 2008-10-09, under 510(k) number K080275.

Who is the listed applicant for NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM?

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

What is the FDA product code for NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM?

The FDA product code for NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM is OMP.

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Related Devices (Code: OMP)

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.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, 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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