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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
510(k) Number K984151
Device Name STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP
Applicant
Mill Pond, Inc.
One Stiles Rd., Suite 104
Salem,  NH  03079
Applicant Contact GREGORY E SANCOFF
Correspondent
Mill Pond, Inc.
One Stiles Rd., Suite 104
Salem,  NH  03079
Correspondent Contact GREGORY E SANCOFF
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received11/19/1998
Decision Date 04/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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