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FDA 510(k), K970594, KALGINATE IMPRESSION MATERIAL
FDA 510(k), K970594, KALGINATE IMPRESSION MATERIAL
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510(K) Number: K970594
Device Name: KALGINATE IMPRESSION MATERIAL
Manufacturer: MICHAEL J RYAN
Device Classification Name: Material, Impression
Regulation Number: ELW
Classification Product Code: 02/18/1997
Date Received: 03/31/1997
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: KALGINATE IMPRESSION MATERIAL
Manufacturer: MICHAEL J RYAN
Device Classification Name: Material, Impression
Regulation Number: ELW
Classification Product Code: 02/18/1997
Date Received: 03/31/1997
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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