TENDERFOOT

Device, Bleeding Time

INTERNATIONAL TECHNIDYNE CORP.

The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Tenderfoot.

Pre-market Notification Details

• Device ID: K883968
• 510k Number: K883968
• Device Name: TENDERFOOT
• Classification: Device, Bleeding Time
• Applicant: INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820
• Contact: Les Heimann
• Correspondent: Les Heimann; INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820
• Product Code: JCA
• CFR Regulation Number: 864.6100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-09-20
• Decision Date: 1988-12-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20711234301194	K883968	000
20711234301187	K883968	000
20711234301163	K883968	000