Device Classification Name |
laser, surgical, gynecologic
|
510(k) Number |
K875078 |
Device Name |
HERACURE LS 500 |
Applicant |
W.C. HERAEUS GMBH |
POSTFACH 1553 |
D-6450 HANAU 1 |
WEST GERMANY,
DE
|
|
Applicant Contact |
WOLFRAM GORISCH |
Correspondent |
W.C. HERAEUS GMBH |
POSTFACH 1553 |
D-6450 HANAU 1 |
WEST GERMANY,
DE
|
|
Correspondent Contact |
WOLFRAM GORISCH |
Regulation Number | 884.4550
|
Classification Product Code |
|
Date Received | 12/29/1987 |
Decision Date | 02/22/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|