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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863284
Device Name I.V. START KIT
Applicant
Welmed Systems, Inc.
P.O. Box 599
West Swanzey,  NH  03469
Applicant Contact DAVID B PETERS
Correspondent
Welmed Systems, Inc.
P.O. Box 599
West Swanzey,  NH  03469
Correspondent Contact DAVID B PETERS
Date Received08/25/1986
Decision Date 09/22/1986
Decision Substantially Equivalent - With Drug (SESD)
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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