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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Suturing, Disposable
510(k) Number K980988
Device Name AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
Applicant
Axya Medical, Inc.
12 S. St.
Marblehead,  MA  01945
Applicant Contact HOWARD L SCHRAYER
Correspondent
Axya Medical, Inc.
12 S. St.
Marblehead,  MA  01945
Correspondent Contact HOWARD L SCHRAYER
Regulation Number878.4800
Classification Product Code
GAB  
Date Received03/17/1998
Decision Date 05/11/1998
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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