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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Cervical, Fixed Size
510(k) Number K791277
Device Name MODEL 6500 EXTRACTION IRRIGATION SYS
Applicant
CAVITRON CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CAVITRON CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.4530
Classification Product Code
HDQ  
Date Received07/10/1979
Decision Date 08/22/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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