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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 K850150
Device Name ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED
Applicant
Gainor Medical
12520 Yellowhead Trl.
Applicant Contact MARK GAINOR
Correspondent
Gainor Medical
12520 Yellowhead Trl.
Correspondent Contact MARK GAINOR
Regulation Number878.4850
Classification Product Code
FMK  
Date Received01/14/1985
Decision Date 02/21/1985
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
Predetermined Change
Control Plan Authorized		 No
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