| Device Classification Name |
Forceps, Biopsy, Non-Electric
|
| 510(k) Number |
K900015 |
| Device Name |
NON-ELECTRIC BIOPSY FORCEPS |
| Applicant |
| Esco Precision, Inc. |
| 21 William Penn Dr. |
|
Stony Brook,
NY
11790
|
|
| Applicant Contact |
TED ESSER |
| Correspondent |
| Esco Precision, Inc. |
| 21 William Penn Dr. |
|
Stony Brook,
NY
11790
|
|
| Correspondent Contact |
TED ESSER |
| Regulation Number | 876.1075 |
| Classification Product Code |
|
| Date Received | 01/02/1990 |
| Decision Date | 03/15/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|