| Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
| 510(k) Number |
K921026 |
| Device Name |
PRESSURE GAUGE |
| Applicant |
| Hobbs Medical, Inc. |
| P.O. Box 46 |
| Spring St. |
|
Stafford Springs,
CT
06076
|
|
| Applicant Contact |
ROBERT G WHALEN |
| Correspondent |
| Hobbs Medical, Inc. |
| P.O. Box 46 |
| Spring St. |
|
Stafford Springs,
CT
06076
|
|
| Correspondent Contact |
ROBERT G WHALEN |
| Regulation Number | 876.5980 |
| Classification Product Code |
|
| Date Received | 03/03/1992 |
| Decision Date | 04/24/1992 |
| 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
|
|
|