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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 K964440
Device Name EUDERMIC HYPOALLERGENIC SURGICAL GLOVES/EUDERMIC SURGICAL GLOVES (VARIOUS)
Applicant
Maxxim Medical
4750 118th Ave. N.
Clearwater,  FL  33762
Applicant Contact JOYCE MOODY
Correspondent
Maxxim Medical
4750 118th Ave. N.
Clearwater,  FL  33762
Correspondent Contact JOYCE MOODY
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/06/1996
Decision Date 04/22/1997
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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