The following data is part of a premarket notification filed by Nissho Corp. with the FDA for Nipro Safelet Cath.
| Device ID | K960051 |
| 510k Number | K960051 |
| Device Name: | NIPRO SAFELET CATH |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | NISSHO CORP. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
| Contact | Luis Candelario |
| Correspondent | Luis Candelario NISSHO CORP. 1384 COPPERFIELD COURT Lexington, KY 40514 -1268 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-04 |
| Decision Date | 1996-03-28 |
| Summary: | summary |