VLOC9ABSORBABLE WOUND CLOSURE DEVICE

Suture, Absorbable, Synthetic, Polyglycolic Acid

SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE

The following data is part of a premarket notification filed by Surgical Devices, A Division Of Tyco Healthcare with the FDA for Vloc9absorbable Wound Closure Device.

Pre-market Notification Details

• Device ID: K100257
• 510k Number: K100257
• Device Name: VLOC9ABSORBABLE WOUND CLOSURE DEVICE
• Classification: Suture, Absorbable, Synthetic, Polyglycolic Acid
• Applicant: SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE 60 MIDDLETOWN AVE. North Haven, CT 06473
• Contact: Jennifer Brennan
• Correspondent: Jennifer Brennan; SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE 60 MIDDLETOWN AVE. North Haven, CT 06473
• Product Code: GAM
• CFR Regulation Number: 878.4493 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-01-28
• Decision Date: 2010-05-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884521132631	K100257	000
20884521132457	K100257	000
20884521132440	K100257	000
20884521132433	K100257	000
20884521132426	K100257	000
20884521132419	K100257	000
20884521132402	K100257	000
20884521132273	K100257	000
20884521132266	K100257	000
20884521132464	K100257	000
20884521132495	K100257	000
20884521132501	K100257	000
20884521132624	K100257	000
20884521132617	K100257	000
20884521132600	K100257	000
20884521132594	K100257	000
20884521132549	K100257	000
20884521132532	K100257	000
20884521132525	K100257	000
20884521132518	K100257	000
20884521132259	K100257	000
20884521132235	K100257	000
20884521132228	K100257	000
20884521818917	K100257	000
20884521803357	K100257	000
20884521140001	K100257	000
20884521818948	K100257	000
20884521818931	K100257	000
20884521827520	K100257	000
20884521827513	K100257	000
20884521818924	K100257	000
20884521803340	K100257	000
20884521131603	K100257	000
20884521131641	K100257	000
20884521131757	K100257	000
20884521131740	K100257	000
20884521131726	K100257	000
20884521131702	K100257	000
20884521131696	K100257	000
20884521131689	K100257	000
20884521131665	K100257	000
20884521131658	K100257	000
20884521818955	K100257	000
90884521131718	K100257	000
20884521171067	K100257	000
20884521162362	K100257	000
20884521143125	K100257	000
20884521140018	K100257	000
20884521139593	K100257	000
20884521135144	K100257	000
20884521135113	K100257	000
20884521135106	K100257	000
20884521175263	K100257	000
10884521528444	K100257	000
20884521132471	K100257	000
20884521132730	K100257	000
20884521132242	K100257	000
10884521135123	K100257	000
10884521132979	K100257	000
10884521131613	K100257	000
00884521132767	K100257	000
20884521131733	K100257	000
20884521131627	K100257	000
20884521133034	K100257	000
20884521133027	K100257	000
20884521133010	K100257	000
20884521132839	K100257	000
20884521132822	K100257	000
20884521132808	K100257	000
20884521132785	K100257	000
20884521132754	K100257	000
20884521132723	K100257	000
20884521132716	K100257	000
20884521132709	K100257	000
20884521132846	K100257	000
20884521132853	K100257	000
20884521132860	K100257	000
20884521133003	K100257	000
20884521132990	K100257	000
20884521132983	K100257	000
20884521132969	K100257	000
20884521132921	K100257	000
20884521132914	K100257	000
20884521132907	K100257	000
20884521132891	K100257	000
20884521132686	K100257	000