The following data is part of a premarket notification filed by Cp Medical with the FDA for Polyglycolic Acid (pga), Absorbable Surgical Suture (usp).
| Device ID | K002190 |
| 510k Number | K002190 |
| Device Name: | POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| 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 | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-20 |
| Decision Date | 2000-08-10 |