PURE-DENT B851 ABSORBABLE DUSTING POWDER
FDA premarket approval P890070/S005 · decided 2011-10-07
Approval details
- PMA number
- P890070
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PURE-DENT B851 ABSORBABLE DUSTING POWDER
- Generic name
- Powder, dusting, surgical
- Applicant
- Grain Processing Corp.
- Date received
- 2011-02-17
- Decision date
- 2011-10-07
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- KGP
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Muscatine, IA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PACMOORE PROCESS TECHNOLOGIES, LLC. IN MOORESVILLE, INDIANA.
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