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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name single use only blood lancet with an integral sharps injury prevention feature
510(k) Number K820333
Device Name MONOJECTOR MONOLET LANCER
Applicant
SHERWOOD MEDICAL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SHERWOOD MEDICAL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4850
Classification Product Code
FMK  
Date Received02/08/1982
Decision Date 03/10/1982
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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