ULTRAFLOW

Apparatus, Air Handling, Room

CUSTOM INDUSTRIES, INC.

The following data is part of a premarket notification filed by Custom Industries, Inc. with the FDA for Ultraflow.

Pre-market Notification Details

• Device ID: K871901
• 510k Number: K871901
• Device Name: ULTRAFLOW
• Classification: Apparatus, Air Handling, Room
• Applicant: CUSTOM INDUSTRIES, INC. 6106 WEST MARKET ST. P.O. BOX 18547 Greensboro, NC 27409
• Contact: Jerry C Lambert
• Correspondent: Jerry C Lambert; CUSTOM INDUSTRIES, INC. 6106 WEST MARKET ST. P.O. BOX 18547 Greensboro, NC 27409
• Product Code: FZH
• CFR Regulation Number: 878.5070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-05-15
• Decision Date: 1987-06-01