The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for Delflex Rigid Drain Container.
| Device ID | K871155 |
| 510k Number | K871155 |
| Device Name: | DELFLEX RIGID DRAIN CONTAINER |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | DELMED, INC. P.O. DRAWER 190 Freehold, NJ 07728 |
| Contact | Doerschuk, Phd |
| Correspondent | Doerschuk, Phd DELMED, INC. P.O. DRAWER 190 Freehold, NJ 07728 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-24 |
| Decision Date | 1987-07-16 |