WoundPro Negative Pressure Wound Therapy System

Negative Pressure Wound Therapy Powered Suction Pump

PENSAR MEDICAL LLC

The following data is part of a premarket notification filed by Pensar Medical Llc with the FDA for Woundpro Negative Pressure Wound Therapy System.

Pre-market Notification Details

• Device ID: K150960
• 510k Number: K150960
• Device Name: WoundPro Negative Pressure Wound Therapy System
• Classification: Negative Pressure Wound Therapy Powered Suction Pump
• Applicant: PENSAR MEDICAL LLC 42225 REMINGTON RD. Temecula, CA 92590
• Contact: Brian Guthrie
• Correspondent: Elaine Duncan; PENSAR MEDICAL LLC Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082
• Product Code: OMP
• CFR Regulation Number: 878.4780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2015-04-10
• Decision Date: 2016-12-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00851978007016	K150960	000
00851978007351	K150960	000
00851978007344	K150960	000
00851978007337	K150960	000
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00851978007092	K150960	000
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00851978007160	K150960	000
00851978007375	K150960	000
00851978007412	K150960	000
00851978007405	K150960	000
00851978007399	K150960	000
00851978007382	K150960	000
00851978007276	K150960	000
00851978007269	K150960	000
00851978007245	K150960	000
00851978007368	K150960	000
00851978007023	K150960	000
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00851978007290	K150960	000
00851978007283	K150960	000
00851978007252	K150960	000
00851978007238	K150960	000
00851978007221	K150960	000
00851978007214	K150960	000
00851978007207	K150960	000
00851978007191	K150960	000
00851978007184	K150960	000
00851978007177	K150960	000
00851978007139	K150960	000
00851978007122	K150960	000
00851978007115	K150960	000
00851978007108	K150960	000
00851978007085	K150960	000
00851978007030	K150960	000
00851978007429	K150960	000