EXTENDED COVERS, STERILE
FDA 510(k) clearance K892069 · decided 1989-08-08
Clearance details
- K-number
- K892069
- Device name
- EXTENDED COVERS, STERILE
- Applicant
- Amedic USA
- Decision
- Substantially Equivalent
- Date received
- 1989-03-31
- Decision date
- 1989-08-08
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- FFF
- Device class
- 1
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sweden, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.