The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Medisystems Apheresis Needle With Guard.
| Device ID | K932074 |
| 510k Number | K932074 |
| Device Name: | MEDISYSTEMS APHERESIS NEEDLE WITH GUARD |
| Classification | Needle, Fistula |
| Applicant | MEDISYSTEMS CORP. THREE EMBARCADERO CENTER 11TH FLOOR San Francisco, CA 94111 |
| Contact | Alan C Hinton |
| Correspondent | Alan C Hinton MEDISYSTEMS CORP. THREE EMBARCADERO CENTER 11TH FLOOR San Francisco, CA 94111 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-28 |
| Decision Date | 1994-02-18 |