TOURNIQUET

Tourniquet, Pneumatic

ASPEN LABORATORIES, INC.

The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Tourniquet.

Pre-market Notification Details

• Device ID: K813231
• 510k Number: K813231
• Device Name: TOURNIQUET
• Classification: Tourniquet, Pneumatic
• Applicant: ASPEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KCY
• CFR Regulation Number: 878.5910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-11-17
• Decision Date: 1981-12-14