BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM

Laparoscope, Gynecologic (and Accessories)

DAVOL, INC.

The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Bard Laparoscopic Irrigator Pump System.

Pre-market Notification Details

Device IDK902722
510k NumberK902722
Device Name:BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston,  RI  02920
ContactAnnette M Fagnant
CorrespondentAnnette M Fagnant
DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston,  RI  02920
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-20
Decision Date1990-11-16

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