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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853265
Device Name ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543
Applicant
Geneva Laboratories, Inc.
P.O. Box 444
Elkhorn,  WI  53121
Applicant Contact GARY L SWANSON
Correspondent
Geneva Laboratories, Inc.
P.O. Box 444
Elkhorn,  WI  53121
Correspondent Contact GARY L SWANSON
Date Received08/05/1985
Decision Date 08/26/1985
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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