Device Classification Name |
gastroscope and accessories, flexible/rigid
|
510(k) Number |
K850020 |
Device Name |
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23 |
Applicant |
PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
MARCIA C STARK |
Correspondent |
PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
MARCIA C STARK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/04/1985 |
Decision Date | 07/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|