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
10810128460993	K100887	000
10810128460771	K100887	000
10810128460764	K100887	000
10810128460757	K100887	000