The following data is part of a premarket notification filed by Nissho Corp. with the FDA for Nipro Scalp Vein Set (disposabl Psv Set).
| Device ID | K955053 |
| 510k Number | K955053 |
| Device Name: | NIPRO SCALP VEIN SET (DISPOSABL PSV SET) |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | NISSHO CORP. 7205 N.W. 19TH ST. SUITE 305 Miami, FL 33126 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-06 |
| Decision Date | 1996-01-04 |