Device Classification Name |
apparatus, suction, single patient use, portable, nonpowered
|
510(k) Number |
K880650 |
Device Name |
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS |
Applicant |
BAXTER HEALTHCARE CORP. |
7280 NORTH CALDWELL |
NILES,
IL
60648
|
|
Applicant Contact |
PETER SPARACIO |
Correspondent |
BAXTER HEALTHCARE CORP. |
7280 NORTH CALDWELL |
NILES,
IL
60648
|
|
Correspondent Contact |
PETER SPARACIO |
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 02/17/1988 |
Decision Date | 02/24/1988 |
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
|