THERMOCOOL SYSTEM— 510(k) K950395
Substantially Equivalent for Some IndicationsZimmer, Inc.
FDA 510(k) clearance K950395 for THERMOCOOL SYSTEM, Substantially Equivalent for Some Indications on 1995-08-18. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Product 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
- Dover, OH, US
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