GPW-SF— 510(k) K011659
Substantially EquivalentGateway Alloys, Inc.
FDA 510(k) clearance K011659 for GPW-SF, Substantially Equivalent on 2001-08-27. Applicant: Gateway Alloys, Inc.. Device class: 2.
Clearance details
- Applicant
- Gateway Alloys, Inc.
- Product code
- Code EJT
- Device class
- Class 2
- Regulation
- 21 CFR 872.3060
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Charles, MO, US
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