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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K861198
Device Name CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)
Applicant
Quali-Med, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Applicant Contact RICK FOSTER
Correspondent
Quali-Med, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Correspondent Contact RICK FOSTER
Date Received03/31/1986
Decision Date 05/16/1986
Decision Substantially Equivalent - With Drug (SESD)
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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