ABSORBABLE DUSTING POWDER
FDA premarket approval N80023/S001 · decided 1998-02-20
Approval details
- PMA number
- N80023
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ABSORBABLE DUSTING POWDER
- Applicant
- Kellerandheckman
- Date received
- 1995-02-27
- Decision date
- 1998-02-20
- Days to decision
- 1089 days
- Decision code
- APPR
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Washington, DC
- Statement
- Approval for a change to the manufacturing process.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CETYLCIDE-G (K974188) | Kellerandheckman | 1998-09-10 |