NORMATEC PCD

Sleeve, Limb, Compressible

NORMATEC, INC.

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

Pre-market Notification Details

• Device ID: K013436
• 510k Number: K013436
• Device Name: NORMATEC PCD
• Classification: Sleeve, Limb, Compressible
• Applicant: NORMATEC, INC. 555 THIREENTH ST. Washington, DC
• Contact: Jonathan S Kahan
• Correspondent: Jonathan S Kahan; NORMATEC, INC. 555 THIREENTH ST. Washington, DC
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-10-16
• Decision Date: 2001-12-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817369020033	K013436	000
00817369020309	K013436	000
00817369020316	K013436	000
00817369020323	K013436	000
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00817369022372	K013436	000