The following data is part of a premarket notification filed by Cp Medical with the FDA for Monoswift.
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MONOSWIFT 77155531 3359217 Live/Registered |
CP Medical 2007-04-12 |