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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K852265
Device Name NON-STERILE GAUZE ROLLER BANDAGES
Applicant
Leonard Joseph Co.
1100 W. 45th Ave.
Denver,  CO  80211
Applicant Contact ALLAN M STRIKER
Correspondent
Leonard Joseph Co.
1100 W. 45th Ave.
Denver,  CO  80211
Correspondent Contact ALLAN M STRIKER
Classification Product Code
EFQ  
Date Received05/24/1985
Decision Date 06/18/1985
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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