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FDA 510(k)

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100

K-Number: K000108 · 2000-05-23

ApplicantBhk Holding
Decision Date2000-05-23
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 is the device name listed in this FDA 510(k) record. The listed applicant is Bhk Holding. It received FDA 510(k) clearance on 2000-05-23 under 510(k) number K000108. 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 RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100?

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 is a medical device that received FDA 510(k) clearance on 2000-05-23. The listed applicant is Bhk Holding. The 510(k) number is K000108.

When did RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 receive FDA 510(k) clearance?

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 received FDA 510(k) clearance on 2000-05-23, under 510(k) number K000108.

Who is the listed applicant for RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100?

The FDA 510(k) record lists Bhk Holding as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100?

The FDA product code for RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 is EMX.

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Related Devices (Code: EMX)

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K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLCK041446NASALCEASELes Laboratorires Brothier, S.A.K993362HYLASINEBiomatrix, Inc.K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLCK982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, Inc.K984069ENTAXIS NASAL PACKINGLes Laboratorires Brothier, S.A.

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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