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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K981800
Device Name SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606
Applicant
Equal Diagnostics, Inc.
115 Summit Dr.
Exton,  PA  19341
Applicant Contact BRENDA Y KAN
Correspondent
Equal Diagnostics, Inc.
115 Summit Dr.
Exton,  PA  19341
Correspondent Contact BRENDA Y KAN
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
DLI  
Date Received05/21/1998
Decision Date 07/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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