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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K993647
Device Name UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F
Applicant
UNIMED SURGICAL PRODUCTS, INC.
10401 BELCHER RD.
LARGO,  FL  33777
Applicant Contact LEE ALEXANDER
Correspondent
UNIMED SURGICAL PRODUCTS, INC.
10401 BELCHER RD.
LARGO,  FL  33777
Correspondent Contact LEE ALEXANDER
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/29/1999
Decision Date 11/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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