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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 K020586
Device Name GOOD LUBRICATIONS
Applicant
BIOFILM, INC.
3121 SCOTT ST.
VISTA,  CA  92083
Applicant Contact ROBERT L DE ARMOND
Correspondent
BIOFILM, INC.
3121 SCOTT ST.
VISTA,  CA  92083
Correspondent Contact ROBERT L DE ARMOND
Regulation Number880.6375
Classification Product Code
KMJ  
Subsequent Product Code
HIS  
Date Received02/22/2002
Decision Date 01/24/2003
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
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