XTEND

Device, External Penile Rigidity

WALLING MEDICAL EQUIPMENT CO.

The following data is part of a premarket notification filed by Walling Medical Equipment Co. with the FDA for Xtend.

Pre-market Notification Details

• Device ID: K980752
• 510k Number: K980752
• Device Name: XTEND
• Classification: Device, External Penile Rigidity
• Applicant: WALLING MEDICAL EQUIPMENT CO. 3000 CANDIDE LN. Mckinney, TX 75070
• Contact: Allan Walling
• Correspondent: Allan Walling; WALLING MEDICAL EQUIPMENT CO. 3000 CANDIDE LN. Mckinney, TX 75070
• Product Code: LKY
• CFR Regulation Number: 876.5020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-02-20
• Decision Date: 1998-05-06
• Summary: summary