MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE— 510(k) K885171
Substantially EquivalentAndover Medical, Inc.
FDA 510(k) clearance K885171 for MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE, Substantially Equivalent on 1989-01-12. Applicant: Andover Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Andover Medical, Inc.
- Product code
- Code DRO
- Device class
- Class 2
- Regulation
- 21 CFR 870.5550
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Haverhill, MA, US
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