IMPLEX CEMENT RESTRICTOR SYSTEM— 510(k) K943378
Substantially EquivalentImplex Corp.
FDA 510(k) clearance K943378 for IMPLEX CEMENT RESTRICTOR SYSTEM, Substantially Equivalent on 1994-09-23. Applicant: Implex Corp.. Device class: 2.
Clearance details
- Applicant
- Implex Corp.
- Product code
- Code LZN
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
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