Device Classification Name |
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
|
510(k) Number |
K801442 |
Device Name |
P-S SURGICAL DRAIN |
Applicant |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 06/20/1980 |
Decision Date | 07/14/1980 |
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
|
|
|