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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K862853
Device Name SYRINGE INJECTION GUN
Applicant
Gastrotech, Inc.
6551 Brecksville Rd.
Independence,  OH  44131
Applicant Contact JEFFREY A GIRIMONT
Correspondent
Gastrotech, Inc.
6551 Brecksville Rd.
Independence,  OH  44131
Correspondent Contact JEFFREY A GIRIMONT
Date Received07/29/1986
Decision Date 08/06/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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