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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K922564
Device Name 6 FRENCH CATHETER
Applicant
S. and H. Engineering, Inc.
4141 NW 132 St.
Miami,  FL  33054
Applicant Contact SYDNEY GOLDSTEIN
Correspondent
S. and H. Engineering, Inc.
4141 NW 132 St.
Miami,  FL  33054
Correspondent Contact SYDNEY GOLDSTEIN
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received06/01/1992
Decision Date 12/17/1992
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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