SIL-MED T-TUBE DRAIN
FDA 510(k) clearance K903989 · decided 1991-01-31
Clearance details
- K-number
- K903989
- Device name
- SIL-MED T-TUBE DRAIN
- Applicant
- Sil-Med Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-29
- Decision date
- 1991-01-31
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- HFL
- Device class
- 2
- Regulation number
- 884.3200
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Taunton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.