FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MENISCAL REPAIR SYSTEM
K Number: K853829
·
Decision Oct 8, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
83
Review Days
25
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Basic Information
- Device Name
- MENISCAL REPAIR SYSTEM
- K Number
- K853829
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Concept, Inc.
- Date Received
- September 13, 1985
- Decision Date
- October 8, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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|---|---|---|---|
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| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | Jun 5, 1990 | Substantially Equivalent for Some Indications |
| K894929 | STAPLE FIXATION SYSTEM | Aug 30, 1989 | Substantially Equivalent |
| K892376 | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) | Aug 1, 1989 | Substantially Equivalent |
| K891109 | PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE | May 8, 1989 | Substantially Equivalent |
| 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 |