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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon, Epistaxis
510(k) Number K000108
Device Name RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
Applicant
Bhk Holding
3234 Ella Ln.
New Port Riche,  FL  34655
Applicant Contact ART WARD
Correspondent
Bhk Holding
3234 Ella Ln.
New Port Riche,  FL  34655
Correspondent Contact ART WARD
Regulation Number874.4100
Classification Product Code
EMX  
Date Received01/14/2000
Decision Date 05/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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