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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K820460
Device Name 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION
Applicant
Superior Plastic Products Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Superior Plastic Products Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6740
Classification Product Code
JOL  
Date Received02/19/1982
Decision Date 03/08/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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