The following data is part of a premarket notification filed by Cp Medical with the FDA for Plain And Chromic Gut Absorbable Surgical Sutures Usp.
Device ID | K001299 |
510k Number | K001299 |
Device Name: | PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP |
Classification | Suture, Absorbable, Natural |
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 | GAL |
CFR Regulation Number | 878.4830 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-24 |
Decision Date | 2000-06-23 |