DAVOL ELECTROSUGICAL PROBES

Coagulator, Laparoscopic, Unipolar (and Accessories)

DAVOL, INC.

The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Davol Electrosugical Probes.

Pre-market Notification Details

Device IDK915406
510k NumberK915406
Device Name:DAVOL ELECTROSUGICAL PROBES
ClassificationCoagulator, Laparoscopic, Unipolar (and Accessories)
Applicant DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston,  RI  02920
ContactRobin Dargo
CorrespondentRobin Dargo
DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston,  RI  02920
Product CodeHFG  
CFR Regulation Number884.4160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-02
Decision Date1992-02-28

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