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FDA 510(k), K971130, DEFEND FLUID RESISTANT PLEATED MASK
FDA 510(k), K971130, DEFEND FLUID RESISTANT PLEATED MASK
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510(K) Number: K971130
Device Name: DEFEND FLUID RESISTANT PLEATED MASK
Manufacturer: CARL PARKER ASSOCIATES, INC.
Device Classification Name: mask, surgical
Regulation Number: 878.4040
Classification Product Code: FXX
Date Received: 03/27/1997
Decision Date: 06/27/1997
Regulation Medical Specialty: General & Plastic Surgery
Device Name: DEFEND FLUID RESISTANT PLEATED MASK
Manufacturer: CARL PARKER ASSOCIATES, INC.
Device Classification Name: mask, surgical
Regulation Number: 878.4040
Classification Product Code: FXX
Date Received: 03/27/1997
Decision Date: 06/27/1997
Regulation Medical Specialty: General & Plastic Surgery
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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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