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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K854095
Device Name BIOPSY TRAY I & II
Applicant
North Coast Medi-Tek
1520-B E. 365 St.
Eastlake,  OH  44094
Applicant Contact THERESA SOLOLOSKI
Correspondent
North Coast Medi-Tek
1520-B E. 365 St.
Eastlake,  OH  44094
Correspondent Contact THERESA SOLOLOSKI
Regulation Number878.4370
Classification Product Code
LRO  
Date Received10/07/1985
Decision Date 11/25/1985
Decision Substantially Equivalent - With Drug (SESD)
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
Recalls CDRH Recalls
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