MODEL 1100 COLD THERAPY DEVICE— 510(k) K970533
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K970533 for MODEL 1100 COLD THERAPY DEVICE, Substantially Equivalent on 1997-04-15. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code ILO
- Device class
- Class 2
- Regulation
- 21 CFR 890.5720
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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