SOFTGOOD PRODUCTS AND SPLINTS— 510(k) K803239
Substantially EquivalentDanek Medical, Inc.
FDA 510(k) clearance K803239 for SOFTGOOD PRODUCTS AND SPLINTS, Substantially Equivalent on 1981-01-09. Applicant: Danek Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Danek Medical, Inc.
- Product code
- Code IPX
- Device class
- Class 1
- Regulation
- 21 CFR 890.3490
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code IPX
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