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FDA 510(k), K884790, QUALTEX NEUROLOK SURGICAL SPONGE
FDA 510(k), K884790, QUALTEX NEUROLOK SURGICAL SPONGE
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510(K) Number: K884790
Device Name: QUALTEX NEUROLOK SURGICAL SPONGE
Manufacturer: DEROYAL INDUSTRIES, INC.
Device Classification Name: gauze/sponge, internal, x-ray detectable
Regulation Number: 878.4450
Classification Product Code: GDY
Date Received: 11/15/1988
Decision Date: 12/09/1988
Regulation Medical Specialty: General & Plastic Surgery
Device Name: QUALTEX NEUROLOK SURGICAL SPONGE
Manufacturer: DEROYAL INDUSTRIES, INC.
Device Classification Name: gauze/sponge, internal, x-ray detectable
Regulation Number: 878.4450
Classification Product Code: GDY
Date Received: 11/15/1988
Decision Date: 12/09/1988
Regulation Medical Specialty: General & Plastic Surgery
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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