The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Pheresis Needle.
| Device ID | K862002 |
| 510k Number | K862002 |
| Device Name: | MEDISYSTEMS PHERESIS NEEDLE |
| Classification | Needle, Fistula |
| Applicant | MEDISYSTEMS CORP. KLEINFELD, KAPLAND & BECKER 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Contact | Peter O Safir |
| Correspondent | Peter O Safir MEDISYSTEMS CORP. KLEINFELD, KAPLAND & BECKER 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-23 |
| Decision Date | 1986-06-27 |