Device Classification Name |
needle, aspiration and injection, disposable
|
510(k) Number |
K962425 |
Device Name |
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) |
Applicant |
RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 |
UPPSALA,
SE
S-754 50
|
|
Applicant Contact |
PER EGNELOV |
Correspondent |
RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 |
UPPSALA,
SE
S-754 50
|
|
Correspondent Contact |
PER EGNELOV |
Regulation Number | 878.4800
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/24/1996 |
Decision Date | 09/11/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|