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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 K931250
Device Name PHYNE-TOUCH PF
Applicant
Medical Resources, Ltd.
1201 Old Hopewell Rd.
Suite 1
Tampa,  FL  33619
Applicant Contact JOSEPH SPICOLA
Correspondent
Medical Resources, Ltd.
1201 Old Hopewell Rd.
Suite 1
Tampa,  FL  33619
Correspondent Contact JOSEPH SPICOLA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/11/1993
Decision Date 01/28/1994
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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