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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chisel (Osteotome)
510(k) Number K952200
Device Name OMNI-JUG
Applicant
Waterstone Medical, Inc.
7200 Wisconsin Ave., Suite 312
Bethesda,  MD  20814
Applicant Contact DANIEL N TRIBASTONE
Correspondent
Waterstone Medical, Inc.
7200 Wisconsin Ave., Suite 312
Bethesda,  MD  20814
Correspondent Contact DANIEL N TRIBASTONE
Regulation Number878.4820
Classification Product Code
KDG  
Date Received05/10/1995
Decision Date 06/29/1995
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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