GENERAL SURGERY DRAPES

Drape, Surgical

WELMED INC.

The following data is part of a premarket notification filed by Welmed Inc. with the FDA for General Surgery Drapes.

Pre-market Notification Details

• Device ID: K070432
• 510k Number: K070432
• Device Name: GENERAL SURGERY DRAPES
• Classification: Drape, Surgical
• Applicant: WELMED INC. 1340 WEST PENNSYLVANIA AVENUE San Diego, CA 92103
• Contact: Glen Feye
• Correspondent: Glen Feye; WELMED INC. 1340 WEST PENNSYLVANIA AVENUE San Diego, CA 92103
• Product Code: KKX
• CFR Regulation Number: 878.4370 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-02-13
• Decision Date: 2007-09-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20849296003364	K070432	000
10849296002797	K070432	000
10849296002346	K070432	000
10849296002339	K070432	000
10849296002322	K070432	000
10849296002315	K070432	000
10849296002308	K070432	000
10849296002292	K070432	000
10849296002285	K070432	000
10849296002278	K070432	000
10849296002261	K070432	000
10849296002803	K070432	000
10849296003015	K070432	000
20849296003357	K070432	000
20849296003340	K070432	000
20849296003333	K070432	000
20849296003326	K070432	000
10849296003312	K070432	000
10849296003305	K070432	000
10849296003299	K070432	000
10849296003220	K070432	000
10849296003213	K070432	000
10849296003206	K070432	000
10849296002254	K070432	000
10849296002247	K070432	000
10849296000724	K070432	000
10849296000717	K070432	000
10849296000700	K070432	000
10849296000694	K070432	000
10849296000687	K070432	000
10849296000670	K070432	000
10849296000663	K070432	000
10849296000113	K070432	000
10849296000106	K070432	000
10849296000090	K070432	000
10849296000731	K070432	000
10849296000748	K070432	000
10849296002230	K070432	000
10849296002223	K070432	000
10849296002216	K070432	000
10849296001745	K070432	000
10849296001431	K070432	000
10849296001219	K070432	000
10849296000786	K070432	000
10849296000779	K070432	000
10849296000762	K070432	000
10849296000755	K070432	000
00849296000017	K070432	000
20849296003371	K070432	000
10849296007112	K070432	000
10849296005347	K070432	000
10849296005309	K070432	000
10849296005293	K070432	000
10849296004005	K070432	000
10849296005033	K070432	000
10849296005026	K070432	000
10849296005019	K070432	000
10849296004944	K070432	000
10849296004654	K070432	000
10849296004609	K070432	000
10849296005354	K070432	000
10849296005514	K070432	000
10849296007099	K070432	000
10849296007006	K070432	000
10849296006986	K070432	000
10849296006474	K070432	000
10849296006313	K070432	000
10849296006290	K070432	000
10849296005606	K070432	000
10849296005590	K070432	000
10849296005583	K070432	000
10849296005576	K070432	000
10849296004531	K070432	000
10849296004463	K070432	000
10849296003633	K070432	000
10849296003558	K070432	000
20849296003463	K070432	000
20849296003456	K070432	000
20849296003449	K070432	000
20849296003432	K070432	000
20849296003425	K070432	000
20849296003418	K070432	000
20849296003401	K070432	000
20849296003395	K070432	000
10849296003640	K070432	000
10849296003688	K070432	000
10849296004456	K070432	000
10849296004449	K070432	000
10849296004432	K070432	000
20849296004170	K070432	000
10849296004036	K070432	000
10849296003879	K070432	000
10849296003855	K070432	000
10849296003848	K070432	000
10849296003831	K070432	000
10849296003770	K070432	000
20849296003388	K070432	000