Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K896146 |
Device Name |
BIOPSY FORCEPS, (NON-RIGID) |
Applicant |
PORTLYN CORP. |
RFD 1, BOX 451 |
ROUTE 25 |
MOULTONBORO,
NH
03254
|
|
Applicant Contact |
JOSEPH SKORUPA |
Correspondent |
PORTLYN CORP. |
RFD 1, BOX 451 |
ROUTE 25 |
MOULTONBORO,
NH
03254
|
|
Correspondent Contact |
JOSEPH SKORUPA |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 10/23/1989 |
Decision Date | 03/09/1990 |
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
|
|
|