EXTRICARE

Negative Pressure Wound Therapy Powered Suction Pump

DEVON MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Devon Medical Products, Inc. with the FDA for Extricare.

Pre-market Notification Details

• Device ID: K110078
• 510k Number: K110078
• Device Name: EXTRICARE
• Classification: Negative Pressure Wound Therapy Powered Suction Pump
• Applicant: DEVON MEDICAL PRODUCTS, INC. 1100 FIRST AVENUE, SUITE 100 King Of Prussia, PA 19406
• Contact: Ruth Wu
• Correspondent: Ruth Wu; DEVON MEDICAL PRODUCTS, INC. 1100 FIRST AVENUE, SUITE 100 King Of Prussia, PA 19406
• Product Code: OMP
• CFR Regulation Number: 878.4780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-01-11
• Decision Date: 2012-02-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20879766005796	K110078	000
20879766005611	K110078	000
20879766005604	K110078	000
10879766005584	K110078	000
10879766005577	K110078	000
10879766005549	K110078	000
10879766005539	K110078	000
10879766005461	K110078	000
14897089070177	K110078	000
14897089070092	K110078	000
20879766005628	K110078	000
20879766005642	K110078	000
20879766005772	K110078	000
20879766005765	K110078	000
20879766005758	K110078	000
20879766005741	K110078	000
20879766005734	K110078	000
20879766005727	K110078	000
10879766005713	K110078	000
10879766005690	K110078	000
20879766005659	K110078	000
14897089070122	K110078	000