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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Surgical, Instrument
510(k) Number K862564
Device Name A.C.L. GUIDE KIT
Applicant
ASPEN LABORATORIES, INC.
P.O. BOX 3936
ENGLEWOOD,  CO  80155 -3936
Applicant Contact JOHNSON
Correspondent
ASPEN LABORATORIES, INC.
P.O. BOX 3936
ENGLEWOOD,  CO  80155 -3936
Correspondent Contact JOHNSON
Regulation Number878.4800
Classification Product Code
FZX  
Date Received07/03/1986
Decision Date 08/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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