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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K905105
Device Name JAIN SUTURE/VESIBAND ORGANIZER
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
MDM  
Date Received11/13/1990
Decision Date 01/31/1991
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
Predetermined Change
Control Plan Authorized		 No
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