CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T— 510(k) K072453
Substantially EquivalentBrymill Corp.
FDA 510(k) clearance K072453 for CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T, Substantially Equivalent on 2007-12-03. Applicant: Brymill Corp.. Device class: 2.
Clearance details
- Applicant
- Brymill Corp.
- Product code
- Code GEH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4350
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ellington, CT, US
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More clearances from Brymill Corp.
view allAdverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
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.