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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 K820587
Device Name WET PACK LINE OF PRODUCTS
Applicant
Abco Dealers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Abco Dealers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received03/04/1982
Decision Date 03/26/1982
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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