The following data is part of a premarket notification filed by U.s. Clinical Products, Inc. with the FDA for Iva Seal Ii.
| Device ID | K812527 |
| 510k Number | K812527 |
| Device Name: | IVA SEAL II |
| Classification | Container, I.v. |
| Applicant | U.S. CLINICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-02 |
| Decision Date | 1981-09-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IVA SEAL II 73292011 1223279 Dead/Cancelled |
U.S. Clinical Products, Inc. 1981-01-06 |