MAYFIELD ADULT 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 Adult Disposable Skull Pin.

Pre-market Notification Details

Device IDK923789
510k NumberK923789
Device Name:MAYFIELD ADULT 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 Received1992-07-28
Decision Date1993-02-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M268A10721 K923789 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.