ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
FDA 510(k) clearance K980917 · decided 1998-05-27
Clearance details
- K-number
- K980917
- Device name
- ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
- Applicant
- Fortune Medical Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-11
- Decision date
- 1998-05-27
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- GCA
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.