Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K071579 |
Device Name |
PEF TUBE |
Applicant |
N.M. BEALE CO. INC. |
5 WHITCOMB AVENEUE |
AYER,
MA
01432
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
N.M. BEALE CO. INC. |
5 WHITCOMB AVENEUE |
AYER,
MA
01432
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 06/08/2007 |
Decision Date | 11/20/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|