The following data is part of a premarket notification filed by Smith & Nephew United, Inc. with the FDA for Opsite I.v. 3000.
| Device ID | K895353 |
| 510k Number | K895353 |
| Device Name: | OPSITE I.V. 3000 |
| Classification | Tape And Bandage, Adhesive |
| Applicant | SMITH & NEPHEW UNITED, INC. 11775 STARKLEY RD. P.O.BOX 1970 Largo, FL 34649 -1970 |
| Contact | Jim Irvin |
| Correspondent | Jim Irvin SMITH & NEPHEW UNITED, INC. 11775 STARKLEY RD. P.O.BOX 1970 Largo, FL 34649 -1970 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-01 |
| Decision Date | 1989-09-28 |