AUTOMATED WASHER
FDA premarket approval P050044/S018 · decided 2011-07-26
Approval details
- PMA number
- P050044
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AUTOMATED WASHER
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2011-06-29
- Decision date
- 2011-07-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- USE OF AN AUTOMATED WASHER AS AN ALTERNATIVE TO MANUAL CLEANING OF EQUIPMENT AND COMPONENTS USED IN THE PRODUCTION OF VITAGEL SURGICAL HEMOSTAT.
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