HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION

Laparoscope, Gynecologic (and Accessories)

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Hydromat Trumpet Valve And Tubing Set For Laparoscopic Suction And Irrigation.

Pre-market Notification Details

Device IDK940462
510k NumberK940462
Device Name:HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw,  GA  30144
ContactPaul L Sumner
CorrespondentPaul L Sumner
KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw,  GA  30144
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-02
Decision Date1994-05-10

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