NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND

Dressing, Wound, Drug

TZ MEDICAL, INC.

The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Neptune Pad, Neptune Disc, Neptune Comfort-band, Comfort-band.

Pre-market Notification Details

• Device ID: K040208
• 510k Number: K040208
• Device Name: NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
• Classification: Dressing, Wound, Drug
• Applicant: TZ MEDICAL, INC. 7272 S.W. DURHAM RD., #800 Portland, OR 97224
• Contact: Madalyn Duncan
• Correspondent: Madalyn Duncan; TZ MEDICAL, INC. 7272 S.W. DURHAM RD., #800 Portland, OR 97224
• 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: 2004-01-30
• Decision Date: 2004-05-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811331010213	K040208	000
00811331011333	K040208	000
00811331010008	K040208	000
00811331010015	K040208	000
00811331011456	K040208	000
00811331010152	K040208	000
00811331010169	K040208	000
00811331010190	K040208	000
00811331010206	K040208	000
00811331011470	K040208	000