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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Disinfectant, Medical Devices
510(k) Number K932277
Device Name LONZA FORMULATION R-82
Applicant
Calgon Vestal Div.
C/O Lonza, Inc.
17-17 Rte. 208
Fair Lawn,  NJ  07410
Applicant Contact JOSEPH R ROBINSON
Correspondent
Calgon Vestal Div.
C/O Lonza, Inc.
17-17 Rte. 208
Fair Lawn,  NJ  07410
Correspondent Contact JOSEPH R ROBINSON
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received05/12/1993
Decision Date 05/12/1994
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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