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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 K820490
Device Name IV START TRAY
Applicant
Seamless Hospital Products Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Seamless Hospital Products Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5200
Classification Product Code
LRS  
Date Received02/23/1982
Decision Date 03/16/1982
Decision Substantially Equivalent (SESE)
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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