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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 K854155
Device Name STERILE SALINE SOLUTION
Applicant
I M, Inc.
P.O. Box 658
Fairfield,  NJ  07004
Applicant Contact AMIR PORAT
Correspondent
I M, Inc.
P.O. Box 658
Fairfield,  NJ  07004
Correspondent Contact AMIR PORAT
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received10/11/1985
Decision Date 12/10/1985
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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