Device Classification Name |
Laser, Surgical, Gynecologic
|
510(k) Number |
K870046 |
Device Name |
DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET |
Applicant |
TTI MEDICAL |
3470 MT. DIABLO BLVD. |
SUITE A 150 |
LAFAYETTE,
CA
94549
|
|
Applicant Contact |
ALLEN R HOWES |
Correspondent |
TTI MEDICAL |
3470 MT. DIABLO BLVD. |
SUITE A 150 |
LAFAYETTE,
CA
94549
|
|
Correspondent Contact |
ALLEN R HOWES |
Regulation Number | 884.4550
|
Classification Product Code |
|
Date Received | 01/05/1987 |
Decision Date | 03/05/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|