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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K864509
Device Name SPARK-KIT(TM)
Applicant
Lyphomed, Inc.
2045 N. Cornell Ave.
Melrose Park,  IL  60160
Applicant Contact DONALD J HARRIGAN
Correspondent
Lyphomed, Inc.
2045 N. Cornell Ave.
Melrose Park,  IL  60160
Correspondent Contact DONALD J HARRIGAN
Date Received11/14/1986
Decision Date 02/18/1987
Decision Substantially Equivalent (SESE)
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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