PRO-GUARD

Wrap, Sterilization

SURGICOT, INC.

The following data is part of a premarket notification filed by Surgicot, Inc. with the FDA for Pro-guard.

Pre-market Notification Details

• Device ID: K830739
• 510k Number: K830739
• Device Name: PRO-GUARD
• Classification: Wrap, Sterilization
• Applicant: SURGICOT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: FRG
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-03-08
• Decision Date: 1983-03-29