Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K003792 |
Device Name |
STRYKER HEATED INSUFFLATOR TUBE SET |
Applicant |
STRYKER CORP. |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051
|
|
Applicant Contact |
MICHAEL BAYCURA |
Correspondent |
STRYKER CORP. |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051
|
|
Correspondent Contact |
MICHAEL BAYCURA |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 12/08/2000 |
Decision Date | 02/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|