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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 K935531
Device Name OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
Applicant
PURITAS HEALTH CARE, INC.
219 KENT RD.
SUITE 20
NEW MILFORD,  CT  06776
Applicant Contact THOMAS P DIMAIO
Correspondent
PURITAS HEALTH CARE, INC.
219 KENT RD.
SUITE 20
NEW MILFORD,  CT  06776
Correspondent Contact THOMAS P DIMAIO
Regulation Number878.4200
Classification Product Code
GBX  
Date Received11/16/1993
Decision Date 05/05/1994
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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