ACUFEX T-FIX DELIVERY SYSTEM— 510(k) K942442
Substantially EquivalentAcufex Microsurgical, Inc.
FDA 510(k) clearance K942442 for ACUFEX T-FIX DELIVERY SYSTEM, Substantially Equivalent on 1994-12-05. Applicant: Acufex Microsurgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Acufex Microsurgical, Inc.
- Product code
- Code MIA
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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