Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
510(k) Number |
K860030 |
Device Name |
SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID |
Applicant |
SURGIDYNE, INC. |
9600 W. 76TH STREET, SUITE D |
EDEN PRAIRIE,
MN
55344
|
|
Applicant Contact |
GEORGE L CARLSON |
Correspondent |
SURGIDYNE, INC. |
9600 W. 76TH STREET, SUITE D |
EDEN PRAIRIE,
MN
55344
|
|
Correspondent Contact |
GEORGE L CARLSON |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 01/06/1986 |
Decision Date | 02/12/1986 |
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
|
|
|