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FDA 510(k)

SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T

K-Number: K994191 · 2000-02-08

ApplicantNmt Medical, Inc.
Decision Date2000-02-08
Product CodeHCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T is the device name listed in this FDA 510(k) record. The listed applicant is Nmt Medical, Inc.. It received FDA 510(k) clearance on 2000-02-08 under 510(k) number K994191. The device is classified under product code HCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T?

SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T is a medical device that received FDA 510(k) clearance on 2000-02-08. The listed applicant is Nmt Medical, Inc.. The 510(k) number is K994191.

When did SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T receive FDA 510(k) clearance?

SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T received FDA 510(k) clearance on 2000-02-08, under 510(k) number K994191.

Who is the listed applicant for SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T?

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

What is the FDA product code for SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T?

The FDA product code for SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T is HCI.

Related Clinical Trials

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.

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Other records listing Nmt Medical, 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.

K034025NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC

Related Devices (Code: HCI)

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.

K221524Sugita AVM Microclip ApplierMizuho America, Inc.K211572Aesculap Slim Clip ApplierAesculap, Inc.K180914Aesculap Slim Clip ApplierAesculap, Inc.K173271Aesculap Slim Clip Applier ForcepsAesculap, Inc.K010910MEDICON YASARGIL CLIP APPLYING FORCEPSMedicon EGK984109AESCULAP AXIAL CLIP APPLIERAesculap, 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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