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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 K903717
Device Name DISPENSA-LUBE
Applicant
Gam-Med Packaging Corp.
712 Anita Ave.
Antioch,  IL  60002
Applicant Contact VAN DYKE
Correspondent
Gam-Med Packaging Corp.
712 Anita Ave.
Antioch,  IL  60002
Correspondent Contact VAN DYKE
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received08/14/1990
Decision Date 09/06/1990
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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