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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K900425
Device Name SURGICAL COTTON GLOVES
Applicant
Allo Pro Corp.
Post Office Box 14159
Clearwater,  FL  34279
Applicant Contact SYLVIA K PIERPOINT
Correspondent
Allo Pro Corp.
Post Office Box 14159
Clearwater,  FL  34279
Correspondent Contact SYLVIA K PIERPOINT
Regulation Number878.4040
Classification Product Code
LYU  
Date Received01/30/1990
Decision Date 09/07/1990
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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