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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K891114
Device Name PATIENT EXAMINATION GLOVE (LATEX)
Applicant
Ambusco Co., Inc.
14 Delta Dr.
New City,  NY  10956
Applicant Contact OLIVER CHIANG
Correspondent
Ambusco Co., Inc.
14 Delta Dr.
New City,  NY  10956
Correspondent Contact OLIVER CHIANG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/02/1989
Decision Date 08/09/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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