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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Anesthesia Face mask; Anesthesia mask, Rotation Mask; Anesthetic mask;EZ mask;Cushion mask; Face mask; Silicone mask; Flexichamber face mask;; Antistatic Silicone Face Mask; Silicone Face Mask
Classification Name: MASK, GAS, ANESTHETIC
Product Code: BSJ
Device Class: 1
Regulation Number: 868.5550
Medical Specialty: Anesthesiology
Registered Establishment Name: FOREMOUNT ENTERPRISE CO., LTD.
Registered Establishment Number: 3010402691
Owner/Operator: FOREMOUNT ENTERPRISE CO., LTD.
Owner/Operator Number: 9042153
Establishment Operations: Contract Manufacturer; Manufacturer
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