Device Classification Name |
Pneumoperitoneum Needle
|
510(k) Number |
K913816 |
Device Name |
ORIGINEEDLE, MODIFICATION |
Applicant |
ORIGIN MEDSYSTEMS, INC. |
1900 SOUTH NORFOLK STREET, |
SUITE 312 |
SAN MATEO,
CA
94403
|
|
Applicant Contact |
FREDERIC H MOLL |
Correspondent |
ORIGIN MEDSYSTEMS, INC. |
1900 SOUTH NORFOLK STREET, |
SUITE 312 |
SAN MATEO,
CA
94403
|
|
Correspondent Contact |
FREDERIC H MOLL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/26/1991 |
Decision Date | 11/08/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|