SMILJANIC BONE REPOSITIONING FORCEPS— 510(k) K871535
Substantially EquivalentLink America, Inc.
FDA 510(k) clearance K871535 for SMILJANIC BONE REPOSITIONING FORCEPS, Substantially Equivalent on 1987-05-14. Applicant: Link America, Inc.. Device class: 1.
Clearance details
- Applicant
- Link America, Inc.
- Product code
- Code HTD
- 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 Hanavor, NJ, US
Recent devices under product code HTD
view allMore clearances from Link America, Inc.
view allAdverse events under product code HTD
product code HTD- Malfunction
- 892
- Total
- 892
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.