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 ID: K932860
• 510k Number: K932860
• Device Name: MAYFIELD ADULT DISPOSABLE SKULL PIN
• Classification: Holder, Head, Neurosurgical (skull Clamp)
• Applicant: OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227
• Contact: Dennis Lackey
• Correspondent: Dennis 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: 1993-06-11
• Decision Date: 1993-09-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M268SGS5601	K932860	000
M268GS5601	K932860	000
M268A10831	K932860	000