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FDA 510(k), K052504, GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
FDA 510(k), K052504, GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
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510(K) Number: K052504
Device Name: GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
Manufacturer: STEPHEN MEADE
Device Classification Name: Elastomer, Silicone Block
Regulation Number: MIB
Classification Product Code: 09/13/2005
Date Received: 11/04/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
Manufacturer: STEPHEN MEADE
Device Classification Name: Elastomer, Silicone Block
Regulation Number: MIB
Classification Product Code: 09/13/2005
Date Received: 11/04/2005
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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