FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENISCECTOMY TRAY #9715
K Number: K823424
·
Decision Mar 17, 1983
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
83
Review Days
121
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Basic Information
- Device Name
- MENISCECTOMY TRAY #9715
- K Number
- K823424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Concept, Inc.
- Date Received
- November 16, 1982
- Decision Date
- March 17, 1983
- Product Code
- HAW
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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| K881954 | CONCEPT POWER SYSTEM | Nov 9, 1988 | Substantially Equivalent |
| K884255 | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM | Nov 8, 1988 | Substantially Equivalent |
| K882121 | C-FLO SUCTION TUBE | Jun 20, 1988 | Substantially Equivalent |
| K880414 | TENDON HARVESTER | Mar 25, 1988 | Substantially Equivalent |