VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

T.A.G. MEDICAL PRODUCTS

The following data is part of a premarket notification filed by T.a.g. Medical Products with the FDA for Versitomic Acl Flexible Reamer System Sterilization Tray.

Pre-market Notification Details

• Device ID: K100887
• 510k Number: K100887
• Device Name: VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: T.A.G. MEDICAL PRODUCTS 291 Hillside Avenue Somerset, MA 02726
• Contact: George J Hattub
• Correspondent: George J Hattub; T.A.G. MEDICAL PRODUCTS 291 Hillside Avenue Somerset, MA 02726
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-03-30
• Decision Date: 2010-08-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327163025	K100887	000
10810190013080	K100887	000
10810190013073	K100887	000
10810190010126	K100887	000