The following data is part of a premarket notification filed by Cp Medical with the FDA for Visorb Swift.
Device ID | K023710 |
510k Number | K023710 |
Device Name: | VISORB SWIFT |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
Contact | Mary Ann Greenawalt |
Correspondent | Mary Ann Greenawalt CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-04 |
Decision Date | 2003-01-17 |
Summary: | summary |