The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Peritoneal Dialysis Sets.
| Device ID | K963668 |
| 510k Number | K963668 |
| Device Name: | MEDISYSTEMS PERITONEAL DIALYSIS SETS |
| Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
| Applicant | MEDISYSTEMS CORP. 1900 K STREET, N.W. Washington, DC 20006 |
| Contact | Larry R Pilot |
| Correspondent | Larry R Pilot MEDISYSTEMS CORP. 1900 K STREET, N.W. Washington, DC 20006 |
| Product Code | KDJ |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-13 |
| Decision Date | 1997-08-15 |
| Summary: | summary |