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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, disposable
510(k) Number K896605
Device Name KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG)
Applicant
NATIONAL-STANDARD MEDICAL PRODUCTS
4445-360 S.W. 35TH TERRACE
GAINESVILLE,  FL  32608
Applicant Contact STEVEN R ROBINSON
Correspondent
NATIONAL-STANDARD MEDICAL PRODUCTS
4445-360 S.W. 35TH TERRACE
GAINESVILLE,  FL  32608
Correspondent Contact STEVEN R ROBINSON
Regulation Number878.4800
Classification Product Code
GAA  
Date Received11/21/1989
Decision Date 01/04/1990
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
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