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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Jet, Mechanical-Powered
510(k) Number K790193
Device Name MIZZY SYRIJET MARK IV
Applicant
Mizzy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Mizzy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.4475
Classification Product Code
EGM  
Date Received01/26/1979
Decision Date 04/23/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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