BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)— 510(k) K992196
Substantially EquivalentHemocleanse, Inc.
FDA 510(k) clearance K992196 for BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK), Substantially Equivalent on 1999-09-10. Applicant: Hemocleanse, Inc.. Device class: 2.
Clearance details
- Applicant
- Hemocleanse, Inc.
- Product code
- Code FLD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5870
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Lafayette, IN, US
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