DRAPES

Drape, Surgical

PFB INTER-APPAREL CORP.

The following data is part of a premarket notification filed by Pfb Inter-apparel Corp. with the FDA for Drapes.

Pre-market Notification Details

• Device ID: K924335
• 510k Number: K924335
• Device Name: DRAPES
• Classification: Drape, Surgical
• Applicant: PFB INTER-APPAREL CORP. 8751 N.W. 102ND ST. Medley, FL 33178
• Contact: Lemke Jr.
• Correspondent: Lemke Jr.; PFB INTER-APPAREL CORP. 8751 N.W. 102ND ST. Medley, FL 33178
• Product Code: KKX
• CFR Regulation Number: 878.4370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-05-22
• Decision Date: 1993-09-07