The following data is part of a premarket notification filed by Cp Medical with the FDA for Stainless Steel Surgical Suture, Non-absorbable.
Device ID | K030351 |
510k Number | K030351 |
Device Name: | STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE |
Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
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 | GAQ |
CFR Regulation Number | 878.4495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-03 |
Decision Date | 2003-03-28 |
Summary: | summary |