The following data is part of a premarket notification filed by Bhk Holding with the FDA for Rapid Rhino-anterior 90mm, Model Rr-a 90, Rapid Rhino-posterior 100mm, Model Rr-p 100.
| Device ID | K000108 |
| 510k Number | K000108 |
| Device Name: | RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 |
| Classification | Balloon, Epistaxis |
| Applicant | BHK HOLDING 3234 ELLA LN. New Port Richey, FL 34655 |
| Contact | Art Ward |
| Correspondent | Art Ward BHK HOLDING 3234 ELLA LN. New Port Richey, FL 34655 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-14 |
| Decision Date | 2000-05-23 |