Device Classification Name |
Laser, Surgical, Gynecologic
|
510(k) Number |
K843515 |
Device Name |
MINUTEMAN CO2 MICROSURGICAL LASER GYN |
Applicant |
AMERICAN SURGICAL LASER, INC. |
600 W CUMMINGS PK |
SUITE 3050 |
WOBURN,
MA
01801
|
|
Applicant Contact |
RICHARD W TUCKER |
Correspondent |
AMERICAN SURGICAL LASER, INC. |
600 W CUMMINGS PK |
SUITE 3050 |
WOBURN,
MA
01801
|
|
Correspondent Contact |
RICHARD W TUCKER |
Regulation Number | 884.4550
|
Classification Product Code |
|
Date Received | 09/05/1984 |
Decision Date | 02/04/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|