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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: KXA
Date Received: 09/13/2005
Decision Date: 11/04/2005
Decision: 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: KXA
Date Received: 09/13/2005
Decision Date: 11/04/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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