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FDA 510(k)

PROCEDUR-10

K-Number: K052075 · 2005-11-09

ApplicantAvanca Medical Devices, Inc.
Decision Date2005-11-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROCEDUR-10 is the device name listed in this FDA 510(k) record. The listed applicant is Avanca Medical Devices, Inc.. It received FDA 510(k) clearance on 2005-11-09 under 510(k) number K052075. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCEDUR-10?

PROCEDUR-10 is a medical device that received FDA 510(k) clearance on 2005-11-09. The listed applicant is Avanca Medical Devices, Inc.. The 510(k) number is K052075.

When did PROCEDUR-10 receive FDA 510(k) clearance?

PROCEDUR-10 received FDA 510(k) clearance on 2005-11-09, under 510(k) number K052075.

Who is the listed applicant for PROCEDUR-10?

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

What is the FDA product code for PROCEDUR-10?

The FDA product code for PROCEDUR-10 is FMF.

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Other records listing Avanca Medical Devices, Inc. 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.

K042487PROCEDUR SF SAFETY SYRINGE DEVICEK042486PROCEDUR 10 SYRINGE DEVICE

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., 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.

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