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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophagoscope (Flexible Or Rigid)
510(k) Number K934193
Device Name CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST
Applicant
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
P.O. Box 1700
Somerville,  NJ  08876
Applicant Contact MARTI DYCK
Correspondent
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
P.O. Box 1700
Somerville,  NJ  08876
Correspondent Contact MARTI DYCK
Regulation Number874.4710
Classification Product Code
EOX  
Date Received08/26/1993
Decision Date 11/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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