PROFORM HIP SYSTEM— 510(k) K934161
Substantially EquivalentStelkast Company
FDA 510(k) clearance K934161 for PROFORM HIP SYSTEM, Substantially Equivalent on 1994-03-10. Applicant: Stelkast Company. Device class: 2.
Clearance details
- Applicant
- Stelkast Company
- Product code
- Code JDO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
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More clearances from Stelkast Company
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- K094035 — EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
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Data sourced from openFDA. This site is unofficial and independent of the FDA.