The following data is part of a premarket notification filed by Cp Medical with the FDA for Polyester Nonabsorbable Surgical Sutures Urp.
Device ID | K001172 |
510k Number | K001172 |
Device Name: | POLYESTER NONABSORBABLE SURGICAL SUTURES URP |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
Contact | Patrick Ferguson |
Correspondent | Patrick Ferguson CP MEDICAL 836 N.E. 24TH AVE. Portland, OR 97232 |
Product Code | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-11 |
Decision Date | 2000-06-23 |