Cleared Traditional

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

K000108 · Bhk Holding · Ear, Nose, Throat

May 2000

Decision

130d

Days

Class 1

Risk

About This 510(k) Submission

K000108 is an FDA 510(k) clearance for the RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100, a Balloon, Epistaxis (Class I — General Controls, product code EMX), submitted by Bhk Holding (New Port Riche, US). The FDA issued a Cleared decision on May 23, 2000, 130 days after receiving the submission on January 14, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4100.

Submission Details

510(k) Number	K000108 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 2000
Decision Date	May 23, 2000
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF