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FDA 510(k), K040053, PRECISION VPS IMPRESSION MATERIAL
FDA 510(k), K040053, PRECISION VPS IMPRESSION MATERIAL
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510(K) Number: K040053
Device Name: PRECISION VPS IMPRESSION MATERIAL
Manufacturer: STEVEN L ZIEMBA
Device Classification Name: Material, Impression
Regulation Number: ELW
Classification Product Code: KXA
Date Received: 01/12/2004
Decision Date: 03/25/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: PRECISION VPS IMPRESSION MATERIAL
Manufacturer: STEVEN L ZIEMBA
Device Classification Name: Material, Impression
Regulation Number: ELW
Classification Product Code: KXA
Date Received: 01/12/2004
Decision Date: 03/25/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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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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