MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE

Suture, Absorbable, Synthetic, Polyglycolic Acid

SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP

The following data is part of a premarket notification filed by Surgical Devices, Tyco Healthcare Group Lp with the FDA for Modification To V-loc 180 Absorbable Wound Closure Device.

Pre-market Notification Details

• Device ID: K091087
• 510k Number: K091087
• Device Name: MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
• Classification: Suture, Absorbable, Synthetic, Polyglycolic Acid
• Applicant: SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP 60 MIDDLETOWN AVE. North Haven, CT 06473
• Contact: Jennifer Brennan
• Correspondent: Jennifer Brennan; SURGICAL DEVICES, TYCO HEALTHCARE GROUP LP 60 MIDDLETOWN AVE. North Haven, CT 06473
• Product Code: GAM
• CFR Regulation Number: 878.4493 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-04-15
• Decision Date: 2009-04-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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