MODIFICATION TO RELIEF BRIEF
FDA 510(k) clearance K003128 · decided 2002-08-12
Clearance details
- K-number
- K003128
- Device name
- MODIFICATION TO RELIEF BRIEF
- Applicant
- The JM Kohn Co.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-06
- Decision date
- 2002-08-12
- Days to decision
- 675 days
- Clearance type
- Traditional
- Product code
- NJB
- Device class
- 1
- Regulation number
- 890.3490
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.