Device Classification Name |
laser, neodymium:yag, pulmonary surgery
|
510(k) Number |
K861045 |
Device Name |
MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT |
Applicant |
SHARPLAN INDUSTRIES, INC. |
C/O KLEINFELD, KAPLAN & BECKER |
1140 NINETEENTH STREET, N.W. |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
PETER SAFIR |
Correspondent |
SHARPLAN INDUSTRIES, INC. |
C/O KLEINFELD, KAPLAN & BECKER |
1140 NINETEENTH STREET, N.W. |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
PETER SAFIR |
Regulation Number | 874.4500
|
Classification Product Code |
|
Date Received | 03/18/1986 |
Decision Date | 04/23/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|