The following data is part of a premarket notification filed by Rush Hampton Industries with the FDA for Universal By Rush-hampton Arthroscopic.
Device ID | K843282 |
510k Number | K843282 |
Device Name: | UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC |
Classification | Forceps, Biopsy, Bronchoscope (non-rigid) |
Applicant | RUSH HAMPTON INDUSTRIES P.O. BOX 5500 Sanford, FL 32772 |
Contact | Stephen E Frazier |
Correspondent | Stephen E Frazier RUSH HAMPTON INDUSTRIES P.O. BOX 5500 Sanford, FL 32772 |
Product Code | BWH |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-20 |
Decision Date | 1984-10-22 |