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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: GOWN, SURGICAL
Product Code: FYA
Device Class: 2
Regulation Number: 878.4040
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: 3A MEDICAL PRODUCTS CO., LTD.
Registered Establishment Number: 3013735189
Premarket Submission Number: K093835
Owner/Operator: 3A Medical Products Co., Ltd.
Owner/Operator Number: 10055456
Establishment Operations: Contract Manufacturer
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