BIOPACK

Lamp, Infrared, Therapeutic Heating

BIOSCAN, INC.

The following data is part of a premarket notification filed by Bioscan, Inc. with the FDA for Biopack.

Pre-market Notification Details

• Device ID: K993685
• 510k Number: K993685
• Device Name: BIOPACK
• Classification: Lamp, Infrared, Therapeutic Heating
• Applicant: BIOSCAN, INC. 6 WALDEN RD. Corrales, NM 87048
• Contact: Butch Smith
• Correspondent: Butch Smith; BIOSCAN, INC. 6 WALDEN RD. Corrales, NM 87048
• Product Code: ILY
• CFR Regulation Number: 890.5500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-01
• Decision Date: 2000-07-18