MAYFIELD RADIOLUCENT 2000 SKULL CLAMP

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 Radiolucent 2000 Skull Clamp.

Pre-market Notification Details

• Device ID: K953124
• 510k Number: K953124
• Device Name: MAYFIELD RADIOLUCENT 2000 SKULL CLAMP
• Classification: Holder, Head, Neurosurgical (skull Clamp)
• Applicant: OHIO MEDICAL INSTRUMENT CO., INC. 3924 VIRGINIA AVE. Cincinnati, OH 45227
• Contact: F. William Sweet
• Correspondent: F. William Sweet; 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: 1995-07-05
• Decision Date: 1996-02-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M268S431A10851	K953124	000
M268437A10921	K953124	000
M268437A10911	K953124	000
M268437A10901	K953124	000
M268437A10891	K953124	000
M268437A10881	K953124	000
M268437A10871	K953124	000
M268437A10821	K953124	000
M268437A10811	K953124	000
M268437A10801	K953124	000
M268437A10791	K953124	000
M268437A10781	K953124	000
M268437A10561	K953124	000
M268A2006A20071	K953124	000
M268A2002SRL1	K953124	000
M268A2002P1	K953124	000
M268437A11011	K953124	000
M268437A11041	K953124	000
M268437A11051	K953124	000
M268437C10841	K953124	000
M268437C1074B1	K953124	000
M268437C10741	K953124	000
M268437C10731	K953124	000
M268437B11411	K953124	000
M268437B10991	K953124	000
M268437B10771	K953124	000
M268437B10751	K953124	000
M268437A11401	K953124	000
M268437A11391	K953124	000
M268437A11381	K953124	000
M268437A11361	K953124	000
M268437A11351	K953124	000
M268437A11071	K953124	000
M268437A11061	K953124	000
M268A20021	K953124	000