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FDA 510(k), K080558, STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
FDA 510(k), K080558, STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
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510(K) Number: K080558
Device Name: STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
Manufacturer: TANIA LUPU
Device Classification Name: Wrap, Sterilization
Regulation Number: FRG
Classification Product Code: KXA
Date Received: 02/28/2008
Decision Date: 12/05/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
Manufacturer: TANIA LUPU
Device Classification Name: Wrap, Sterilization
Regulation Number: FRG
Classification Product Code: KXA
Date Received: 02/28/2008
Decision Date: 12/05/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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