STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK

Lavage, Jet

STRYKER INSTRUMENTS

The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Stryker Interpulse Handpiece Set, Splash Shields, Irrigation And Suction Tips, Rechargeable Battery Pack.

Pre-market Notification Details

Device IDK972069
510k NumberK972069
Device Name:STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK
ClassificationLavage, Jet
Applicant STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,  MI  49001
ContactTammmy Lounds
CorrespondentTammmy Lounds
STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,  MI  49001
Product CodeFQH  
CFR Regulation Number880.5475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-03
Decision Date1997-07-29
Summary:summary

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