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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K950159
Device Name SURESHARP
Applicant
Gainor Medical U.S.A., Inc.
2205 Hwy. 42 N.
P.O. Box 353
Mcdonough,  GA  30253
Applicant Contact WILLIAM C TAYLOR
Correspondent
Gainor Medical U.S.A., Inc.
2205 Hwy. 42 N.
P.O. Box 353
Mcdonough,  GA  30253
Correspondent Contact WILLIAM C TAYLOR
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/17/1995
Decision Date 04/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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