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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K841676
Device Name DISPOSABLE POLY GLOVES
Applicant
Abco Dealers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Abco Dealers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/23/1984
Decision Date 05/22/1984
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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