FOREIGN BODY PROTECTOR

Endoscopic Access Overtube, Gastroenterology-urology

JAYCO PHARMACEUTICALS

The following data is part of a premarket notification filed by Jayco Pharmaceuticals with the FDA for Foreign Body Protector.

Pre-market Notification Details

• Device ID: K841258
• 510k Number: K841258
• Device Name: FOREIGN BODY PROTECTOR
• Classification: Endoscopic Access Overtube, Gastroenterology-urology
• Applicant: JAYCO PHARMACEUTICALS 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: FED
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-03-26
• Decision Date: 1984-07-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10350770928101	K841258	000