510(k) K052770
- Device
- PATHFORMER
- Applicant
- PATH SCIENTIFIC, LLC
- 510(k) number
- K052770
- Product code
- NWF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-10-31
- Date received
- 2005-09-30
- Regulation
- 878.4820
- Classification name
- Drill, Battery Powered, Subungual Hematoma
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATSY J TRISLER
- Address
- 5600 Wisconsin Ave., # 509 Chevy Chase MD US 20815 20815
FDA Registration Numbers#
- 3031564283
- 3006897996
- 3013846070
- 3006760998
- 3015972835
Source Documents#
Legacy Summary#
summary
FDA Review#
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