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FDA 510(k)

NASAL SEPTAL BUTTON

K-Number: K972060 · 1997-07-03

ApplicantBoston Medical Products, Inc.
Decision Date1997-07-03
Product CodeLFB
DecisionSubstantially Equivalent

Device Summary

NASAL SEPTAL BUTTON 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 K972060. The device is classified under product code LFB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASAL SEPTAL BUTTON?

NASAL SEPTAL BUTTON 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 K972060.

When did NASAL SEPTAL BUTTON receive FDA 510(k) clearance?

NASAL SEPTAL BUTTON received FDA 510(k) clearance on 1997-07-03, under 510(k) number K972060.

Who is the listed applicant for NASAL SEPTAL BUTTON?

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 NASAL SEPTAL BUTTON?

The FDA product code for NASAL SEPTAL BUTTON is LFB.

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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: LFB)

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.

K131745BLOM-SINGER SEPTAL PERFORATION PROSTHESISHelix Medical, LLCK013696SILMED NASAL SEPTAL BUTTONSilmed, Inc.K982667MICROMEDICS NASAL SEPTAL BUTTONMicromedics, Inc.K920994HOOD NASAL SEPTAL BUTTONHood LaboratoriesK901366INVOTEC SEPTAL BUTTONInvotec International, Inc.K871072OMEGA NASAL SEPTAL BUTTONOmega Silicone, Inc.

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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