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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K864015
Device Name STERILABELS
Applicant
Diversatronics, Inc.
620 Pkwy.
Broomall,  PA  19008
Applicant Contact WILFRED KLEIN
Correspondent
Diversatronics, Inc.
620 Pkwy.
Broomall,  PA  19008
Correspondent Contact WILFRED KLEIN
Classification Product Code
LDQ
Date Received10/15/1986
Decision Date 12/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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