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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K875315
Device Name I.V. START KITS
Applicant
Ni-Med, Inc.
12624 W. 10 Mile Rd.
South Lyon,  MI  48178
Applicant Contact HOWARD MEADE
Correspondent
Ni-Med, Inc.
12624 W. 10 Mile Rd.
South Lyon,  MI  48178
Correspondent Contact HOWARD MEADE
Regulation Number880.5200
Classification Product Code
LRS  
Date Received12/29/1987
Decision Date 02/17/1988
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General Hospital
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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