STERILE BIOPSY NEEDLES
FDA 510(k) clearance K853559 · decided 1985-09-11
Clearance details
- K-number
- K853559
- Device name
- STERILE BIOPSY NEEDLES
- Applicant
- Plasmedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-26
- Decision date
- 1985-09-11
- Days to decision
- 16 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.