PIDURAL STEROID SYSTEM

Anesthesia Conduction Kit

PROFESSIONAL MEDICAL DEVICE CONSULTANTS

The following data is part of a premarket notification filed by Professional Medical Device Consultants with the FDA for Pidural Steroid System.

Pre-market Notification Details

• Device ID: K945484
• 510k Number: K945484
• Device Name: PIDURAL STEROID SYSTEM
• Classification: Anesthesia Conduction Kit
• Applicant: PROFESSIONAL MEDICAL DEVICE CONSULTANTS 561 EAST FAIROAKS WAY Sandy, UT 84070
• Contact: John B Rowe
• Correspondent: John B Rowe; PROFESSIONAL MEDICAL DEVICE CONSULTANTS 561 EAST FAIROAKS WAY Sandy, UT 84070
• Product Code: CAZ
• CFR Regulation Number: 868.5140 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-08
• Decision Date: 1995-06-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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