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FDA 510(k), K981091, NEOCOLLOID, ORTHOPRINT
FDA 510(k), K981091, NEOCOLLOID, ORTHOPRINT
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510(K) Number: K981091
Device Name: NEOCOLLOID, ORTHOPRINT
Manufacturer: ZHERMACK S.P.A.
Device Classification Name: material, impression
Regulation Number: 872.3660
Classification Product Code: ELW
Date Received: 03/25/1998
Decision Date: 05/21/1998
Regulation Medical Specialty: Dental
Device Name: NEOCOLLOID, ORTHOPRINT
Manufacturer: ZHERMACK S.P.A.
Device Classification Name: material, impression
Regulation Number: 872.3660
Classification Product Code: ELW
Date Received: 03/25/1998
Decision Date: 05/21/1998
Regulation Medical Specialty: Dental
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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