GOODLEY POLYAXIAL CERVICAL TRACTION UNIT
FDA 510(k) clearance K854248 · decided 1985-11-15
Clearance details
- K-number
- K854248
- Device name
- GOODLEY POLYAXIAL CERVICAL TRACTION UNIT
- Applicant
- E-Z-Em, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-21
- Decision date
- 1985-11-15
- Days to decision
- 25 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Westbury, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.