MONOSWIFT

Suture, Absorbable, Synthetic, Polyglycolic Acid

CP MEDICAL

The following data is part of a premarket notification filed by Cp Medical with the FDA for Monoswift.

Pre-market Notification Details

• Device ID: K072229
• 510k Number: K072229
• Device Name: MONOSWIFT
• Classification: Suture, Absorbable, Synthetic, Polyglycolic Acid
• Applicant: CP MEDICAL 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518
• Contact: Betsy Cortelloni
• Correspondent: Betsy Cortelloni; CP MEDICAL 5203 BRISTOL INDUSTRIAL WAY Buford, GA 30518
• Product Code: GAM
• CFR Regulation Number: 878.4493 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-10
• Decision Date: 2007-10-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841336118857	K072229	000
10841336118635	K072229	000
10841336118628	K072229	000
10841336118611	K072229	000
10841336118604	K072229	000
10841336118581	K072229	000
00841336118577	K072229	000
10841336117768	K072229	000
10841336117751	K072229	000
10841336117744	K072229	000
10841336117737	K072229	000
10841336117720	K072229	000
10841336117706	K072229	000
10841336117690	K072229	000
10841336117683	K072229	000
10841336118642	K072229	000
00841336118669	K072229	000
10841336118680	K072229	000
10841336118840	K072229	000
10841336118833	K072229	000
10841336118826	K072229	000
00841336118812	K072229	000
10841336118802	K072229	000
00841336118799	K072229	000
10841336118789	K072229	000
10841336118772	K072229	000
10841336118758	K072229	000
10841336118741	K072229	000
10841336118734	K072229	000
10841336118727	K072229	000
10841336118710	K072229	000
10841336118703	K072229	000
00841336100374	K072229	000