Device Classification Name |
apparatus, suction, single patient use, portable, nonpowered
|
510(k) Number |
K813341 |
Device Name |
WOUND-EVAC |
Applicant |
HERITAGE MEDICAL PRODUCTS |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
HERITAGE MEDICAL PRODUCTS |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 11/25/1981 |
Decision Date | 12/18/1981 |
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
|
|
|