Device Classification Name |
Apparatus, Exhaust, Surgical
|
510(k) Number |
K001082 |
Device Name |
STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 |
Applicant |
STACKHOUSE, INC. |
1100 BIRD CENTER DR. |
PALM SPRINGS,
CA
92262
|
|
Applicant Contact |
TOM GUTIERREZ |
Correspondent |
STACKHOUSE, INC. |
1100 BIRD CENTER DR. |
PALM SPRINGS,
CA
92262
|
|
Correspondent Contact |
TOM GUTIERREZ |
Regulation Number | 878.5070
|
Classification Product Code |
|
Date Received | 04/04/2000 |
Decision Date | 06/15/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|