VIEWPOINT ENT/ORTHOPEDIC OPTION

Neurological Stereotaxic Instrument

PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Viewpoint Ent/orthopedic Option.

Pre-market Notification Details

Device IDK991256
510k NumberK991256
Device Name:VIEWPOINT ENT/ORTHOPEDIC OPTION
ClassificationNeurological Stereotaxic Instrument
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland,  OH  44143
ContactElaine K Keeler
CorrespondentElaine K Keeler
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland,  OH  44143
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-13
Decision Date1999-10-08
Summary:summary

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