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FDA 510(k), K123234, ERMIS STERILIZATION CONTAINER SYSTEM
FDA 510(k), K123234, ERMIS STERILIZATION CONTAINER SYSTEM
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510(K) Number: K123234
Device Name: ERMIS STERILIZATION CONTAINER SYSTEM
Manufacturer: ANDRE WEINGERL
Device Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation Number: KCT
Classification Product Code: KXA
Date Received: 10/15/2012
Decision Date: 07/05/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: ERMIS STERILIZATION CONTAINER SYSTEM
Manufacturer: ANDRE WEINGERL
Device Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation Number: KCT
Classification Product Code: KXA
Date Received: 10/15/2012
Decision Date: 07/05/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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