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FDA 510(k), K101128, BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
FDA 510(k), K101128, BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
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$149.00 USD
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$149.00 USD
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510(K) Number: K101128
Device Name: BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
Manufacturer: IAN GORDON
Device Classification Name: Surgical Mask With Antimicrobial/Antiviral Agent
Regulation Number: OUK
Classification Product Code: 04/22/2010
Date Received: 05/26/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013
Manufacturer: IAN GORDON
Device Classification Name: Surgical Mask With Antimicrobial/Antiviral Agent
Regulation Number: OUK
Classification Product Code: 04/22/2010
Date Received: 05/26/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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