SHARPE ENDOTENACULUM

Laparoscope, Gynecologic (and Accessories)

PALADIN MEDICAL, INC.

The following data is part of a premarket notification filed by Paladin Medical, Inc. with the FDA for Sharpe Endotenaculum.

Pre-market Notification Details

Device IDK915743
510k NumberK915743
Device Name:SHARPE ENDOTENACULUM
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater,  MN  55082 -0560
ContactElaine Duncan
CorrespondentElaine Duncan
PALADIN MEDICAL, INC. P.O. BOX 560 Stillwater,  MN  55082 -0560
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-23
Decision Date1993-05-20

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