Device Classification Name |
speculum, vaginal, nonmetal
|
510(k) Number |
K922154 |
Device Name |
INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION |
Applicant |
OLSEN ELECTROSURGICAL, INC. |
2100 MERIDIAN PARK BLVD. |
CONCORD,
CA
94520
|
|
Applicant Contact |
EUGENE W OLSEN |
Correspondent |
OLSEN ELECTROSURGICAL, INC. |
2100 MERIDIAN PARK BLVD. |
CONCORD,
CA
94520
|
|
Correspondent Contact |
EUGENE W OLSEN |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 05/07/1992 |
Decision Date | 04/21/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|