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FDA 510(k), K951220, HEMA-GLU
FDA 510(k), K951220, HEMA-GLU
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510(K) Number: K951220
Device Name: HEMA-GLU
Manufacturer: HEALTH-DENT INTL., INC.
Device Classification Name: agent, tooth bonding, resin
Regulation Number: 872.3200
Classification Product Code: KLE
Date Received: 03/20/1995
Decision Date: 05/12/1995
Regulation Medical Specialty: Dental
Device Name: HEMA-GLU
Manufacturer: HEALTH-DENT INTL., INC.
Device Classification Name: agent, tooth bonding, resin
Regulation Number: 872.3200
Classification Product Code: KLE
Date Received: 03/20/1995
Decision Date: 05/12/1995
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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