CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)

Laparoscope, Gynecologic (and Accessories)

INNERVISION, INC.

The following data is part of a premarket notification filed by Innervision, Inc. with the FDA for Christoudias Gauze Dissector (laparoscopic Hand Instrument).

Pre-market Notification Details

Device IDK982428
510k NumberK982428
Device Name:CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant INNERVISION, INC. 6258 SHADY GROVE RD. E. Memphis,  TN  38120
ContactFrank M Lewis
CorrespondentFrank M Lewis
INNERVISION, INC. 6258 SHADY GROVE RD. E. Memphis,  TN  38120
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-13
Decision Date1998-10-09

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