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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 K944969
Device Name STERI-LUB LUBRICATION GEL
Applicant
Horizon Medical, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Applicant Contact PHILLIP L RITGER
Correspondent
Horizon Medical, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Correspondent Contact PHILLIP L RITGER
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received10/11/1994
Decision Date 02/27/1995
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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