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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Irrigating (Non Dental)
510(k) Number K902854
Device Name GRAVITY ASSIST
Applicant
Instrument Makar, Inc.
2950 E. Mt. Hope Rd.
Okemos,  MI  48864
Applicant Contact DEAN LOOK
Correspondent
Instrument Makar, Inc.
2950 E. Mt. Hope Rd.
Okemos,  MI  48864
Correspondent Contact DEAN LOOK
Regulation Number880.6960
Classification Product Code
KYZ  
Date Received06/29/1990
Decision Date 08/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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