MODULAR TROCAR SYSTEM
FDA 510(k) clearance K060096 · decided 2006-01-24
Clearance details
- K-number
- K060096
- Device name
- MODULAR TROCAR SYSTEM
- Applicant
- Applied Medical Resources Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-13
- Decision date
- 2006-01-24
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rancho Santa, CA, US
- Third-party review
- Yes
- Expedited review
- No
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