OSTEOPOWER SYSTEM AND ACCESSORIES— 510(k) K971692
Substantially EquivalentOsteomed Corp.
FDA 510(k) clearance K971692 for OSTEOPOWER SYSTEM AND ACCESSORIES, Substantially Equivalent on 1997-06-27. Applicant: Osteomed Corp.. Device class: 2.
Clearance details
- Applicant
- Osteomed Corp.
- Product code
- Code KMW
- Device class
- Class 2
- Regulation
- 21 CFR 872.4120
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
Recent devices under product code KMW
view allMore clearances from Osteomed Corp.
view allAdverse events under product code KMW
product code KMW- Injury
- 175
- Total
- 175
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 →
Recalls naming K971692
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971692.
Data sourced from openFDA. This site is unofficial and independent of the FDA.