SPONGETRAC

Scale, Sponge, Surgical, Electrically-powered

SURGITRAC CORP.

The following data is part of a premarket notification filed by Surgitrac Corp. with the FDA for Spongetrac.

Pre-market Notification Details

• Device ID: K964181
• 510k Number: K964181
• Device Name: SPONGETRAC
• Classification: Scale, Sponge, Surgical, Electrically-powered
• Applicant: SURGITRAC CORP. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109
• Contact: Jonathan S Kahan
• Correspondent: Jonathan S Kahan; SURGITRAC CORP. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109
• Product Code: MRL
• CFR Regulation Number: 880.2740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-10-18
• Decision Date: 1997-02-26