MAYFIELD CHILD DISPOSABLE SKULL PIN

Holder, Head, Neurosurgical (skull Clamp)

OHIO MEDICAL INSTRUMENT CO., INC.

The following data is part of a premarket notification filed by Ohio Medical Instrument Co., Inc. with the FDA for Mayfield Child Disposable Skull Pin.

Pre-market Notification Details

Device IDK941558
510k NumberK941558
Device Name:MAYFIELD CHILD DISPOSABLE SKULL PIN
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati,  OH  45227
ContactDennis R Lackey
CorrespondentDennis R Lackey
OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati,  OH  45227
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-31
Decision Date1995-12-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M268A10841 K941558 000

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