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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Changer, Radiographic Film/Cassette
510(k) Number K935157
Device Name ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES
Applicant
Regulatory Consultants TO the Medical Device Indus
9712 S. Altamont Dr.
Sandy,  UT  84092
Applicant Contact WILLIAM E MCKAY
Correspondent
Regulatory Consultants TO the Medical Device Indus
9712 S. Altamont Dr.
Sandy,  UT  84092
Correspondent Contact WILLIAM E MCKAY
Regulation Number892.1860
Classification Product Code
KPX  
Subsequent Product Code
IYO  
Date Received10/28/1993
Decision Date 08/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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