MD TECH BIOPSY SET FOR BONE AND BONE MARROW— 510(k) K961959
Substantially EquivalentMedical Device Technologies, Inc.
FDA 510(k) clearance K961959 for MD TECH BIOPSY SET FOR BONE AND BONE MARROW, Substantially Equivalent on 1996-07-19. Applicant: Medical Device Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- Medical Device Technologies, Inc.
- Product code
- Code GAA
- 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
- Gainsville, FL, US
Recent devices under product code GAA
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- K050873 — CANALIZER HYDROPHILIC GUIDE WIRE
- K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
Adverse events under product code GAA
product code GAA- Malfunction
- 834
- Total
- 834
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.