STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281— 510(k) K984340
Substantially EquivalentSterngold/Implamed
FDA 510(k) clearance K984340 for STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281, Substantially Equivalent on 1999-01-08. Applicant: Sterngold/Implamed. Device class: 2.
Clearance details
- Applicant
- Sterngold/Implamed
- Product code
- Code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Attleboro, MA, US
Recent devices under product code EMA
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- K982895 — STERNOMEGA COMPOMER CEMENT
- K981516 — STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB
Data sourced from openFDA. This site is unofficial and independent of the FDA.