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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K911087
Device Name CASTLE WASHER/DISINFECTOR, MODEL 7550
Applicant
Mdt Biologic Co.
1777 E. Henrietta Rd.
P.O. Box 23077
Rochester,  NY  14692
Applicant Contact FREDERICK R CATT
Correspondent
Mdt Biologic Co.
1777 E. Henrietta Rd.
P.O. Box 23077
Rochester,  NY  14692
Correspondent Contact FREDERICK R CATT
Date Received03/11/1991
Decision Date 08/09/1993
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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