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FDA 510(k)

MONTGOMERY THYROPLASTY IMPLANT SYSTEM

K-Number: K972317 · 1997-09-18

ApplicantBoston Medical Products, Inc.
Decision Date1997-09-18
Product CodeMIX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MONTGOMERY THYROPLASTY IMPLANT SYSTEM 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 1997-09-18 under 510(k) number K972317. The device is classified under product code MIX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONTGOMERY THYROPLASTY IMPLANT SYSTEM?

MONTGOMERY THYROPLASTY IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-18. The listed applicant is Boston Medical Products, Inc.. The 510(k) number is K972317.

When did MONTGOMERY THYROPLASTY IMPLANT SYSTEM receive FDA 510(k) clearance?

MONTGOMERY THYROPLASTY IMPLANT SYSTEM received FDA 510(k) clearance on 1997-09-18, under 510(k) number K972317.

Who is the listed applicant for MONTGOMERY THYROPLASTY IMPLANT SYSTEM?

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 MONTGOMERY THYROPLASTY IMPLANT SYSTEM?

The FDA product code for MONTGOMERY THYROPLASTY IMPLANT SYSTEM is MIX.

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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 STENTSK972459RHINOCELL NASAL PACKINGSK972096BIVALVE NASAL SPLINTK972078POST-STOP EPISTAXIS CATHETERK972092NASAL AIRWAY SPLINTK972151DOYLE COMBO NASAL AIRWAY SPLINT

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Related Devices (Code: MIX)

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.

K240919Silk Voice (SMI-04)Sofregen MedicalK180631Silk VoiceSofregen Medical, Inc.K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTCytophil, Inc.K083783VF LIQUIGELCoapt Systems, Inc.K081816VOCALIS AND VOCALIS SMCytophil, Inc.K081815VOCALIS GELCytophil, 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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