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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 K822510
Device Name SUCTION CATHETER W/STERILE WATER
Applicant
MEDINE DYNACOR
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDINE DYNACOR
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4200
Classification Product Code
GBX  
Date Received08/20/1982
Decision Date 10/13/1982
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
Recalls CDRH Recalls
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