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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K862289
Device Name KOREAN GREEN CROSS SCALP VEIN SET
Applicant
Sturbridge Medical
Suite K
2081 Bering Dr.
San Jose,  CA  95131
Applicant Contact HARRY B GARDNER
Correspondent
Sturbridge Medical
Suite K
2081 Bering Dr.
San Jose,  CA  95131
Correspondent Contact HARRY B GARDNER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/17/1986
Decision Date 09/23/1986
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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