The following data is part of a premarket notification filed by Medi-plast Intl., Inc. with the FDA for I.v. Bottle (ridgid).
| Device ID | K811234 |
| 510k Number | K811234 |
| Device Name: | I.V. BOTTLE (RIDGID) |
| Classification | Container, I.v. |
| Applicant | MEDI-PLAST INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-04 |
| Decision Date | 1981-06-18 |