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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retainer, surgical
510(k) Number K904536
Device Name JAIN GRAFT ASSIST
Applicant
JAIN SURGICAL EQUIPMENT, INC.
7829 SPRINKLE RD.
KALAMAZOO,  MI  49001
Applicant Contact MELISA ROOT
Correspondent
JAIN SURGICAL EQUIPMENT, INC.
7829 SPRINKLE RD.
KALAMAZOO,  MI  49001
Correspondent Contact MELISA ROOT
Regulation Number878.4800
Classification Product Code
GCZ  
Date Received10/04/1990
Decision Date 11/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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