Device Classification Name |
speculum, vaginal, metal, fiberoptic
|
510(k) Number |
K864865 |
Device Name |
SPECULUM, VAGINAL, METAL FIBEROPTIC |
Applicant |
LUXTEC CORP. |
P.O. BOX 225, RTE 20/49 |
TECHNO PARK RD |
STURBRIDGE,
MA
01566
|
|
Applicant Contact |
THOMAS WILK |
Correspondent |
LUXTEC CORP. |
P.O. BOX 225, RTE 20/49 |
TECHNO PARK RD |
STURBRIDGE,
MA
01566
|
|
Correspondent Contact |
THOMAS WILK |
Regulation Number | 884.4520
|
Classification Product Code |
|
Date Received | 12/11/1986 |
Decision Date | 01/09/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|