I.V. BOTTLE (RIDGID)
FDA 510(k) clearance K811234 · decided 1981-06-18
Clearance details
- K-number
- K811234
- Device name
- I.V. BOTTLE (RIDGID)
- Applicant
- Medi-Plast Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-04
- Decision date
- 1981-06-18
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- KPE
- Device class
- 2
- Regulation number
- 880.5025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek ma recall (Z-2641-2024) | Microtek Medical Inc. | 2024-08-16 |