Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K983050 |
Device Name |
PNEUMATIC CUTTER SYSTEM |
Applicant |
SURGICAL LASER TECHNOLOGIES, INC. |
147 KEYSTONE DR. |
MONTGOMERYVILLE,
PA
18936
|
|
Applicant Contact |
MONICA FERRANTE |
Correspondent |
SURGICAL LASER TECHNOLOGIES, INC. |
147 KEYSTONE DR. |
MONTGOMERYVILLE,
PA
18936
|
|
Correspondent Contact |
MONICA FERRANTE |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 09/01/1998 |
Decision Date | 11/25/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|