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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K873527
Device Name DECHERNEY HYSTEROSCOPY PUMP SYSTEM
Applicant
Cabot Medical Corp.
2021 Cabot Blvd. W.
Langhorne,  PA  19047
Applicant Contact JACK KELLER
Correspondent
Cabot Medical Corp.
2021 Cabot Blvd. W.
Langhorne,  PA  19047
Correspondent Contact JACK KELLER
Regulation Number884.1700
Classification Product Code
HIG  
Date Received09/01/1987
Decision Date 02/26/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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