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FDA 510(k)

CUSTOM NASAL SPLINT

K-Number: K972082 · 1997-07-03

ApplicantBoston Medical Products, Inc.
Decision Date1997-07-03
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUSTOM NASAL SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Boston Medical Products, Inc.. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K972082. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM NASAL SPLINT?

CUSTOM NASAL SPLINT is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Boston Medical Products, Inc.. The 510(k) number is K972082.

When did CUSTOM NASAL SPLINT receive FDA 510(k) clearance?

CUSTOM NASAL SPLINT received FDA 510(k) clearance on 1997-07-03, under 510(k) number K972082.

Who is the listed applicant for CUSTOM NASAL SPLINT?

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

What is the FDA product code for CUSTOM NASAL SPLINT?

The FDA product code for CUSTOM NASAL SPLINT is LYA.

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Other records listing Boston Medical Products, 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.

K091135RUTTER SUPRA STOMAL STENTSK972317MONTGOMERY THYROPLASTY IMPLANT SYSTEMK972459RHINOCELL NASAL PACKINGSK972096BIVALVE NASAL SPLINTK972078POST-STOP EPISTAXIS CATHETERK972092NASAL AIRWAY SPLINT

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Related Devices (Code: LYA)

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.

K243655TurbAlignSpirair, Inc.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLCK202623Novapak Nasal Sinus Packing and StentMedtronic XomedK181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLC

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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