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FDA 510(k), K072251, MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
FDA 510(k), K072251, MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
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510(K) Number: K072251
Device Name: MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
Manufacturer: DONNA COLEMAN
Device Classification Name: Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Regulation Number: LZJ
Classification Product Code: 08/13/2007
Date Received: 05/08/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
Manufacturer: DONNA COLEMAN
Device Classification Name: Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Regulation Number: LZJ
Classification Product Code: 08/13/2007
Date Received: 05/08/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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