COVERSLIPPER
FDA 510(k) clearance K780261 · decided 1978-04-18
Clearance details
- K-number
- K780261
- Device name
- COVERSLIPPER
- Applicant
- Shandon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-16
- Decision date
- 1978-04-18
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- KIM
- Device class
- 1
- Regulation number
- 864.3400
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.