Device Classification Name |
Saw, Surgical, Ent (Electric Or Pneumatic)
|
510(k) Number |
K800669 |
Device Name |
FELDMAN MINI-SAW, #300000 |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 03/26/1980 |
Decision Date | 04/21/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|