Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K912611 |
Device Name |
OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE |
Applicant |
OLSEN ELECTROSURGICAL, INC. |
2100 MERIDIAN PARK BLVD. |
CONCORD,
CA
94520
|
|
Applicant Contact |
MARIA MURSELL |
Correspondent |
OLSEN ELECTROSURGICAL, INC. |
2100 MERIDIAN PARK BLVD. |
CONCORD,
CA
94520
|
|
Correspondent Contact |
MARIA MURSELL |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/12/1991 |
Decision Date | 04/15/1992 |
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
|