Device Classification Name |
Needle, Catheter
|
510(k) Number |
K900374 |
Device Name |
ADAIR/VERESS NEEDLE INTRODUCER SET |
Applicant |
MEDICAL DYNAMICS, INC. |
99 INVERNESS DR., EAST |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
JO BREHM |
Correspondent |
MEDICAL DYNAMICS, INC. |
99 INVERNESS DR., EAST |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
JO BREHM |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 01/26/1990 |
Decision Date | 04/20/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|