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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K850266
Device Name AMERICAN PHARMASEAL STERILE I.V. START KIT
Applicant
American Pharmaseal Div. Ahsc
1015 Grandview
P.O. Box 1300
Glendale,  CA  91209
Applicant Contact LAWRENCE W GETLIN
Correspondent
American Pharmaseal Div. Ahsc
1015 Grandview
P.O. Box 1300
Glendale,  CA  91209
Correspondent Contact LAWRENCE W GETLIN
Date Received01/23/1985
Decision Date 03/22/1985
Decision Substantially Equivalent (SESE)
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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