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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Floor Standing
510(k) Number K891759
Device Name KINETIC MODEL 330
Applicant
Kinetic Biomedical Services, Inc.
4934 Peach St.
Erie,  PA  16509
Applicant Contact JAMES I LAUGHNER
Correspondent
Kinetic Biomedical Services, Inc.
4934 Peach St.
Erie,  PA  16509
Correspondent Contact JAMES I LAUGHNER
Regulation Number878.4580
Classification Product Code
FSS  
Date Received03/23/1989
Decision Date 04/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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