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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K942486
Device Name IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE
Applicant
Mdt Corp., Inc.
1777 E. Henrietta Rd.
Rochester,  NY  14623
Applicant Contact MARK N SMITH, P.E.
Correspondent
Mdt Corp., Inc.
1777 E. Henrietta Rd.
Rochester,  NY  14623
Correspondent Contact MARK N SMITH, P.E.
Regulation Number878.4960
Classification Product Code
FQO  
Subsequent Product Codes
FWW   GDL  
Date Received05/25/1994
Decision Date 08/10/1994
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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