Device Classification Name |
Retractor, Fiberoptic
|
510(k) Number |
K964561 |
Device Name |
ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA |
Applicant |
BIOENTERICS CORP. |
1035A CINDY LN. |
CARPINTERIA,
CA
93013
|
|
Applicant Contact |
KEITH LOWREY |
Correspondent |
BIOENTERICS CORP. |
1035A CINDY LN. |
CARPINTERIA,
CA
93013
|
|
Correspondent Contact |
KEITH LOWREY |
Regulation Number | 876.4530
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/13/1996 |
Decision Date | 02/11/1997 |
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
|
|
|