ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543
FDA 510(k) clearance K853265 · decided 1985-08-26
Clearance details
- K-number
- K853265
- Device name
- ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543
- Applicant
- Geneva Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-05
- Decision date
- 1985-08-26
- Days to decision
- 21 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Elkhorn, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.