| Device Classification Name |
Catheter, Peritoneal, Long-Term Indwelling
|
| 510(k) Number |
K903502 |
| Device Name |
LIFECOIL CATHETER |
| Applicant |
| Lifemed of California |
| 2059 Del Amo Blvd. |
|
Compton,
CA
90220
|
|
| Applicant Contact |
PATRICIA BRINKER |
| Correspondent |
| Lifemed of California |
| 2059 Del Amo Blvd. |
|
Compton,
CA
90220
|
|
| Correspondent Contact |
PATRICIA BRINKER |
| Regulation Number | 876.5630 |
| Classification Product Code |
|
| Date Received | 08/03/1990 |
| Decision Date | 10/22/1990 |
| 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
|
|
|