OXYGENATOR

Chamber, Oxygen, Topical, Extremity

ADJUNCTIVE THERAPEUTICS, INC.

The following data is part of a premarket notification filed by Adjunctive Therapeutics, Inc. with the FDA for Oxygenator.

Pre-market Notification Details

• Device ID: K002632
• 510k Number: K002632
• Device Name: OXYGENATOR
• Classification: Chamber, Oxygen, Topical, Extremity
• Applicant: ADJUNCTIVE THERAPEUTICS, INC. 10 SCOTCH MIST COURT Potomac, MD 20854
• Contact: Myron Z Bernstein
• Correspondent: Myron Z Bernstein; ADJUNCTIVE THERAPEUTICS, INC. 10 SCOTCH MIST COURT Potomac, MD 20854
• Product Code: KPJ
• CFR Regulation Number: 878.5650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-08-23
• Decision Date: 2001-10-25