The following data is part of a premarket notification filed by Pharma-plast Usa, Inc. with the FDA for Nipro Safelet Cath.
| Device ID | K894371 |
| 510k Number | K894371 |
| Device Name: | NIPRO SAFELET CATH |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | PHARMA-PLAST USA, INC. 26133 US 19 N Clearwater, FL 34623 |
| Contact | Lindemann, Boc |
| Correspondent | Lindemann, Boc PHARMA-PLAST USA, INC. 26133 US 19 N Clearwater, FL 34623 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-10-25 |