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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K864824
Device Name INFECTIOUS TISSUE KIT
Applicant
American Scientific Products
1430 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact ROBERTA A BUCKNER
Correspondent
American Scientific Products
1430 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact ROBERTA A BUCKNER
Date Received12/09/1986
Decision Date 12/24/1986
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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