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FDA 510(k), K905119, PLAZLYTE(TM)
FDA 510(k), K905119, PLAZLYTE(TM)
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$149.00 USD
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510(K) Number: K905119
Device Name: PLAZLYTE(TM)
Manufacturer: ABTOX, INC.
Device Classification Name: sterilizer, ethylene-oxide gas
Regulation Number: 880.6860
Classification Product Code: FLF
Date Received: 11/14/1990
Decision Date: 12/22/1994
Regulation Medical Specialty: General Hospital
Device Name: PLAZLYTE(TM)
Manufacturer: ABTOX, INC.
Device Classification Name: sterilizer, ethylene-oxide gas
Regulation Number: 880.6860
Classification Product Code: FLF
Date Received: 11/14/1990
Decision Date: 12/22/1994
Regulation Medical Specialty: General Hospital
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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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