BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER

Needle, Hypodermic, Single Lumen

RETRACTABLE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Blood Collection Tube Holder Vanishpoint Tube Holder/small Tube Adapter.

Pre-market Notification Details

• Device ID: K971763
• 510k Number: K971763
• Device Name: BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LANE, P.O. BOX 9 Little Elm, TX 75068 -0009
• Contact: Terance Grisso
• Correspondent: Terance Grisso; RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LANE, P.O. BOX 9 Little Elm, TX 75068 -0009
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-05-13
• Decision Date: 1997-08-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613703227119	K971763	000
00613703227027	K971763	000