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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Cystometric, Electric
510(k) Number K942485
Device Name MDT UROLOGY TABLE
Applicant
Mdt Corp., Inc.
1777 E. Henrietta Rd.
Rochester,  NY  14623
Applicant Contact MARK N SMITH
Correspondent
Mdt Corp., Inc.
1777 E. Henrietta Rd.
Rochester,  NY  14623
Correspondent Contact MARK N SMITH
Regulation Number876.4890
Classification Product Code
MMZ  
Date Received05/25/1994
Decision Date 08/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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