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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853559
Device Name STERILE BIOPSY NEEDLES
Applicant
Plasmedics, Inc.
6404 S. Quebec
Englewood,  CO  80111
Applicant Contact LOUIS R DILTS
Correspondent
Plasmedics, Inc.
6404 S. Quebec
Englewood,  CO  80111
Correspondent Contact LOUIS R DILTS
Date Received08/26/1985
Decision Date 09/11/1985
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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