PermeaDerm B, PermeaDerm CW, And PermeaDerm Glove

Dressing, Wound, Drug

PERMEADERM, INC.

The following data is part of a premarket notification filed by Permeaderm, Inc. with the FDA for Permeaderm B, Permeaderm Cw, And Permeaderm Glove.

Pre-market Notification Details

• Device ID: K153678
• 510k Number: K153678
• Device Name: PermeaDerm B, PermeaDerm CW, And PermeaDerm Glove
• Classification: Dressing, Wound, Drug
• Applicant: PERMEADERM, INC. 2905 SEGOVIA WAY Carlsbad, CA 92009
• Contact: Aubrey Woodroof
• Correspondent: Aubrey Woodroof; PERMEADERM, INC. 2905 SEGOVIA WAY Carlsbad, CA 92009
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-21
• Decision Date: 2016-08-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10810125740104	K153678	000
00810125740022	K153678	000
00810125740039	K153678	000
00810125740046	K153678	000
00810125740053	K153678	000
00810125740060	K153678	000
00810125740077	K153678	000
00810125740084	K153678	000
00810125740183	K153678	000
00810125740190	K153678	000
00810125740206	K153678	000
10810125741378	K153678	000
00810125740015	K153678	000
00810125740008	K153678	000
10810125740111	K153678	000
10810125740173	K153678	000
10810125740210	K153678	000
10810125741040	K153678	000
10810125741071	K153678	000
10810125741101	K153678	000
10810125742214	K153678	000
10810125742221	K153678	000
10810125742238	K153678	000
10810125742245	K153678	000
10810125742252	K153678	000
10810125741408	K153678	000
10810125742092	K153678	000
10810125742535	K153678	000
10810125742542	K153678	000
10810125742559	K153678	000
00856880007321	K153678	000
00856880007017	K153678	000
00856880007024	K153678	000
00856880007031	K153678	000
00856880007048	K153678	000
00856880007055	K153678	000
00856880007215	K153678	000
00856880007222	K153678	000
10810125742528	K153678	000
10810125742511	K153678	000
10810125742122	K153678	000
10810125742153	K153678	000
10810125742610	K153678	000
10810125742627	K153678	000
10810125742634	K153678	000
10810125742641	K153678	000
10810125742658	K153678	000
10810125742665	K153678	000
10810125741941	K153678	000
10810125741972	K153678	000
10810125742009	K153678	000
00856880007246	K153678	000