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FDA 510(k), K974520, SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
FDA 510(k), K974520, SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
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510(K) Number: K974520
Device Name: SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
Manufacturer: INNOVATIVE TECHNOLOGIES (US), INC.
Device Classification Name: dressing, wound and burn, occlusive
Regulation Number:
Classification Product Code: MGP
Date Received: 12/02/1997
Decision Date: 02/06/1998
Regulation Medical Specialty:
Device Name: SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM
Manufacturer: INNOVATIVE TECHNOLOGIES (US), INC.
Device Classification Name: dressing, wound and burn, occlusive
Regulation Number:
Classification Product Code: MGP
Date Received: 12/02/1997
Decision Date: 02/06/1998
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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