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FDA 510(k)

RHINOCELL NASAL PACKINGS

K-Number: K972459 · 1997-08-04

ApplicantBoston Medical Products, Inc.
Decision Date1997-08-04
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RHINOCELL NASAL PACKINGS 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 1997-08-04 under 510(k) number K972459. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHINOCELL NASAL PACKINGS?

RHINOCELL NASAL PACKINGS is a medical device that received FDA 510(k) clearance on 1997-08-04. The listed applicant is Boston Medical Products, Inc.. The 510(k) number is K972459.

When did RHINOCELL NASAL PACKINGS receive FDA 510(k) clearance?

RHINOCELL NASAL PACKINGS received FDA 510(k) clearance on 1997-08-04, under 510(k) number K972459.

Who is the listed applicant for RHINOCELL NASAL PACKINGS?

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 RHINOCELL NASAL PACKINGS?

The FDA product code for RHINOCELL NASAL PACKINGS is EMX.

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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 SYSTEMK972096BIVALVE NASAL SPLINTK972078POST-STOP EPISTAXIS CATHETERK972092NASAL AIRWAY SPLINTK972151DOYLE COMBO NASAL AIRWAY SPLINT

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Related Devices (Code: EMX)

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.

K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk HoldingK993362HYLASINEBiomatrix, Inc.K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, 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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