The following data is part of a premarket notification filed by Janin Group, Inc. with the FDA for Ash Advantage Peritoneal Catheter.
| Device ID | K991042 |
| 510k Number | K991042 |
| Device Name: | ASH ADVANTAGE PERITONEAL CATHETER |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | JANIN GROUP, INC. 615 ENTERPRISE ST. Aurora, IL 60504 -8138 |
| Contact | John A Navis |
| Correspondent | John A Navis JANIN GROUP, INC. 615 ENTERPRISE ST. Aurora, IL 60504 -8138 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-29 |
| Decision Date | 1999-06-25 |
| Summary: | summary |