The following data is part of a premarket notification filed by Central Plastic, Inc. with the FDA for Disposable Iv Induction Cover.
| Device ID | K894427 |
| 510k Number | K894427 |
| Device Name: | DISPOSABLE IV INDUCTION COVER |
| Classification | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Applicant | CENTRAL PLASTIC, INC. P.O. BOX 789 Eldorado, KS 67042 |
| Contact | Philip Hisle |
| Correspondent | Philip Hisle CENTRAL PLASTIC, INC. P.O. BOX 789 Eldorado, KS 67042 |
| Product Code | FMK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-09-11 |