AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED— 510(k) K896122
Substantially EquivalentSpectramed, Inc.
FDA 510(k) clearance K896122 for AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED, Substantially Equivalent on 1990-01-19. Applicant: Spectramed, Inc.. Device class: 2.
Clearance details
- Applicant
- Spectramed, Inc.
- Product code
- Code KXO
- Device class
- Class 2
- Regulation
- 21 CFR 884.2700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oxnard, CA, US
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