PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16— 510(k) K040835
Substantially EquivalentPm Devices, Inc.
FDA 510(k) clearance K040835 for PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16, Substantially Equivalent on 2004-06-15. Applicant: Pm Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Pm Devices, Inc.
- Product code
- Code FTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richmond, Bc, CA
Recent devices under product code FTM
view allMore clearances from Pm Devices, Inc.
view allAdverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
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.