Device Classification Name |
Laryngostroboscope
|
510(k) Number |
K801866 |
Device Name |
PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A |
Applicant |
PENTAX PRECISION INSTRUMENT CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
PENTAX PRECISION INSTRUMENT CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.4750
|
Classification Product Code |
|
Date Received | 08/05/1980 |
Decision Date | 09/16/1980 |
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
|
|
|