Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K915816 |
Device Name |
BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY |
Applicant |
GI SUPPLY |
423N. 21ST ST. |
CAMP HILL,
PA
17011
|
|
Applicant Contact |
FRANK W JACKSON |
Correspondent |
GI SUPPLY |
423N. 21ST ST. |
CAMP HILL,
PA
17011
|
|
Correspondent Contact |
FRANK W JACKSON |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 12/30/1991 |
Decision Date | 03/27/1992 |
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
|
|
|