Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
510(k) Number |
K831085 |
Device Name |
SYNEVAC VACUUM SOURCE UNIT |
Applicant |
SYNEMED, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SYNEMED, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 04/04/1983 |
Decision Date | 06/08/1983 |
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
|
|
|