K780202 is an FDA 510(k) clearance for the MONOMER EVACUATION SYSTEM. This device is classified as a Evacuator, Vapor, Cement Monomer (Class I - General Controls, product code JDY).
Submitted by Medishield, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1978, 14 days after receiving the submission on February 7, 1978.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4220.
| 510(k) Number | K780202 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 1978 |
| Decision Date | February 21, 1978 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDY — Evacuator, Vapor, Cement Monomer |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4220 |