BOARD, DISPOSABLE CONTROL COUNT
FDA 510(k) clearance K781791 · decided 1978-11-08
Clearance details
- K-number
- K781791
- Device name
- BOARD, DISPOSABLE CONTROL COUNT
- Applicant
- Dexide, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-10-20
- Decision date
- 1978-11-08
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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.