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FDA 510(k), K060832, RETRO-TECH DRESSING
FDA 510(k), K060832, RETRO-TECH DRESSING
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510(K) Number: K060832
Device Name: RETRO-TECH DRESSING
Manufacturer: GRACE HOLLAND
Device Classification Name: Dressing, Wound, Drug
Regulation Number: FRO
Classification Product Code: KXA
Date Received: 03/27/2006
Decision Date: 03/13/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: RETRO-TECH DRESSING
Manufacturer: GRACE HOLLAND
Device Classification Name: Dressing, Wound, Drug
Regulation Number: FRO
Classification Product Code: KXA
Date Received: 03/27/2006
Decision Date: 03/13/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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