HOTMAN— 510(k) K952172
Substantially EquivalentHemo Sapiens, Inc.
FDA 510(k) clearance K952172 for HOTMAN, Substantially Equivalent on 1997-06-10. Applicant: Hemo Sapiens, Inc.. Device class: 2.
Clearance details
- Applicant
- Hemo Sapiens, Inc.
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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