SPRIO-LOOP— 510(k) K811419
Substantially EquivalentDatamed, Inc.
FDA 510(k) clearance K811419 for SPRIO-LOOP, Substantially Equivalent on 1981-06-12. Applicant: Datamed, Inc.. Device class: 1.
Clearance details
- Applicant
- Datamed, Inc.
- Product code
- Code BTX
- Device class
- Class 1
- Regulation
- 21 CFR 878.3910
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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