ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION— 510(k) K880990
Substantially EquivalentAlpha-Tec Systems, Inc.
FDA 510(k) clearance K880990 for ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION, Substantially Equivalent on 1988-03-24. Applicant: Alpha-Tec Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Alpha-Tec Systems, Inc.
- Product code
- Code JSY
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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