SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2— 510(k) K020252
Substantially EquivalentHarvest Technologies, Corp.
FDA 510(k) clearance K020252 for SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2, Substantially Equivalent on 2002-04-05. Applicant: Harvest Technologies, Corp.. Device class: 2.
Clearance details
- Applicant
- Harvest Technologies, Corp.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MA, US
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- K011032 — SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.