READI-STRAND; MODEL PSSTRAND
FDA 510(k) clearance K020337 · decided 2002-07-29
Clearance details
- K-number
- K020337
- Device name
- READI-STRAND; MODEL PSSTRAND
- Applicant
- Worldwide Medical Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2002-02-01
- Decision date
- 2002-07-29
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- KXK
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Woodbury, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.