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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Patient
510(k) Number K073684
Device Name SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
Applicant
Sheffield Industries, Div. of Faria , Ltd.
170 Broad St.
New London,  CT  06320
Applicant Contact KATHLEEN HACKU
Correspondent
Sheffield Industries, Div. of Faria , Ltd.
170 Broad St.
New London,  CT  06320
Correspondent Contact KATHLEEN HACKU
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received12/28/2007
Decision Date 05/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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