The following data is part of a premarket notification filed by Superior Plastic Products Corp. with the FDA for No. 5300-3 1/2 French Umbilical Vessel Cath. Etc..
| Device ID | K851981 |
| 510k Number | K851981 |
| Device Name: | NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC. |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | SUPERIOR PLASTIC PRODUCTS CORP. COLUMBIA INDUSTRIAL PARK Cumberland, RI 02864 |
| Contact | Paul Bernard |
| Correspondent | Paul Bernard SUPERIOR PLASTIC PRODUCTS CORP. COLUMBIA INDUSTRIAL PARK Cumberland, RI 02864 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-07 |
| Decision Date | 1985-06-18 |