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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K920405
Device Name STERILE SURGEON'S GOWN
Applicant
Amsco Sterile Recoveries, Inc.
55 Northern Blvd.
Suite 301
Great Neck,  NY  11201
Applicant Contact CAROLANN DOTULA-COOK
Correspondent
Amsco Sterile Recoveries, Inc.
55 Northern Blvd.
Suite 301
Great Neck,  NY  11201
Correspondent Contact CAROLANN DOTULA-COOK
Regulation Number878.4040
Classification Product Code
FYA  
Date Received01/31/1992
Decision Date 08/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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