Device Classification Name |
light source, endoscope, xenon arc
|
510(k) Number |
K921315 |
Device Name |
PENTAX XENON LIGHT SOURCE |
Applicant |
PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
LORRAINE SCHWARTZ |
Correspondent |
PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
LORRAINE SCHWARTZ |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/18/1992 |
Decision Date | 06/25/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|