SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
FDA 510(k) clearance K980092 · decided 1998-03-09
Clearance details
- K-number
- K980092
- Device name
- SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1998-01-09
- Decision date
- 1998-03-09
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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