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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K840323
Device Name SILICONE SUCTION & IRRIGATION DRAIN
Applicant
SUPERIOR PLASTIC PRODUCTS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SUPERIOR PLASTIC PRODUCTS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4200
Classification Product Code
GBX  
Date Received01/25/1984
Decision Date 04/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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