GENERAL PURPOSE ATL NEEDLE GUIDE KIT

Transducer, Ultrasonic, Diagnostic

PROTEK MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Protek Medical Products, Inc. with the FDA for General Purpose Atl Needle Guide Kit.

Pre-market Notification Details

• Device ID: K973958
• 510k Number: K973958
• Device Name: GENERAL PURPOSE ATL NEEDLE GUIDE KIT
• Classification: Transducer, Ultrasonic, Diagnostic
• Applicant: PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245
• Contact: Rick L Pruter
• Correspondent: Rick L Pruter; PROTEK MEDICAL PRODUCTS, INC. 221 E. MARKET ST. SUITE 291 Iowa City, IA 52245
• Product Code: ITX
• CFR Regulation Number: 892.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-10-16
• Decision Date: 1998-01-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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