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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 K895557
Device Name PATIENT EXAMINATION GLOVES
Applicant
Moeller Chemicals, Inc.
50 Chestnut Ridge Rd., Suite
102
Montvale,  NJ  07645
Applicant Contact GREGORY J RUMMO
Correspondent
Moeller Chemicals, Inc.
50 Chestnut Ridge Rd., Suite
102
Montvale,  NJ  07645
Correspondent Contact GREGORY J RUMMO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/23/1989
Decision Date 11/17/1989
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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