SCALPEL

Scalpel, One-piece

ISOLAB, INC.

The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Scalpel.

Pre-market Notification Details

• Device ID: K780998
• 510k Number: K780998
• Device Name: SCALPEL
• Classification: Scalpel, One-piece
• Applicant: ISOLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GDX
• CFR Regulation Number: 878.4800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-06-14
• Decision Date: 1978-07-27