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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K904598
Device Name ACCU PATH STERILE LABEL
Applicant
Accu-Path
P.O. Box 2215
Lilburn,  GA  30247
Applicant Contact JAMES C PHELAN
Correspondent
Accu-Path
P.O. Box 2215
Lilburn,  GA  30247
Correspondent Contact JAMES C PHELAN
Classification Product Code
LDQ
Date Received10/10/1990
Decision Date 10/30/1990
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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