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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853801
Device Name MENISCAL STITCHING KIT
Applicant
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155
Applicant Contact JOHNSON
Correspondent
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155
Correspondent Contact JOHNSON
Date Received09/11/1985
Decision Date 10/08/1985
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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