THORASTAT ATR-XXXX— 510(k) K870792
Substantially EquivalentGish Biomedical, Inc.
FDA 510(k) clearance K870792 for THORASTAT ATR-XXXX, Substantially Equivalent on 1987-04-28. Applicant: Gish Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Gish Biomedical, Inc.
- Product code
- Code DTP
- Device class
- Class 2
- Regulation
- 21 CFR 870.4230
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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