SINGLE USE INSTRUMENT TRAY— 510(k) K962328
Substantially EquivalentMedcare Medical Group, Inc.
FDA 510(k) clearance K962328 for SINGLE USE INSTRUMENT TRAY, Substantially Equivalent on 1996-08-09. Applicant: Medcare Medical Group, Inc.. Device class: 1.
Clearance details
- Applicant
- Medcare Medical Group, Inc.
- Product code
- Code FSM
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Swanzey, NH, US
Recent devices under product code FSM
view allMore clearances from Medcare Medical Group, Inc.
view allAdverse events under product code FSM
product code FSM- Malfunction
- 1,289
- Total
- 1,289
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.