MODEL 1100 COLD THERAPY DEVICE— 510(k) K955057
Substantially Equivalent for Some IndicationsSmith and Nephew Donjoy, Inc.
FDA 510(k) clearance K955057 for MODEL 1100 COLD THERAPY DEVICE, Substantially Equivalent for Some Indications on 1996-03-08. Applicant: Smith and Nephew Donjoy, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith and Nephew Donjoy, 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 for Some Indications
- Clearance type
- Traditional
- Location
- Carsbad, CA, US
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