Device Classification Name |
Nasopharyngoscope (Flexible Or Rigid)
|
510(k) Number |
K921707 |
Device Name |
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2 |
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 | 874.4760
|
Classification Product Code |
|
Date Received | 04/10/1992 |
Decision Date | 07/01/1992 |
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
|
Recalls |
CDRH Recalls
|