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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K891308
Device Name STERILE SURGICAL GLOVES
Applicant
Carl Parker Associates, Inc.
175m Commerce Dr.
P.O. Box 12084
Hauppauge,  NY  11788
Applicant Contact CARL PARKER
Correspondent
Carl Parker Associates, Inc.
175m Commerce Dr.
P.O. Box 12084
Hauppauge,  NY  11788
Correspondent Contact CARL PARKER
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/09/1989
Decision Date 04/26/1989
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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