EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)

Laparoscope, General & Plastic Surgery

SHIPPERT MEDICAL TECHNOLOGIES CORP.

The following data is part of a premarket notification filed by Shippert Medical Technologies Corp. with the FDA for Expandacell Anti-fog Instrument Wipe (with Alcohol)/(without).

Pre-market Notification Details

Device IDK964334
510k NumberK964334
Device Name:EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)
ClassificationLaparoscope, General & Plastic Surgery
Applicant SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood,  CO  80112
ContactSarah Maxwell Lake
CorrespondentSarah Maxwell Lake
SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood,  CO  80112
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-31
Decision Date1996-12-09
Summary:summary

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