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.
Device ID | K941558 |
510k Number | K941558 |
Device Name: | MAYFIELD CHILD DISPOSABLE SKULL PIN |
Classification | Holder, Head, Neurosurgical (skull Clamp) |
Applicant | OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227 |
Contact | Dennis R Lackey |
Correspondent | Dennis R Lackey OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227 |
Product Code | HBL |
CFR Regulation Number | 882.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-31 |
Decision Date | 1995-12-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M268A10841 | K941558 | 000 |