PROACT WITH GEL OR PROACT 1— 510(k) K052243
Substantially EquivalentProact, Inc.
FDA 510(k) clearance K052243 for PROACT WITH GEL OR PROACT 1, Substantially Equivalent on 2006-04-12. Applicant: Proact, Inc.. Device class: 2.
Clearance details
- Applicant
- Proact, Inc.
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Recent devices under product code JOW
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