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FDA 510(k), K040080, AESCULAP ABSORBABLE CRANIOFIX
FDA 510(k), K040080, AESCULAP ABSORBABLE CRANIOFIX
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510(K) Number: K040080
Device Name: AESCULAP ABSORBABLE CRANIOFIX
Manufacturer: MATTHEW M HULL
Device Classification Name: Cover, Burr Hole
Regulation Number: GXR
Classification Product Code: KXA
Date Received: 01/15/2004
Decision Date: 03/31/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: AESCULAP ABSORBABLE CRANIOFIX
Manufacturer: MATTHEW M HULL
Device Classification Name: Cover, Burr Hole
Regulation Number: GXR
Classification Product Code: KXA
Date Received: 01/15/2004
Decision Date: 03/31/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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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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