The following data is part of a premarket notification filed by Promedica Products, Inc. with the FDA for Peters Cardionyl(tm) Suture.
| Device ID | K913102 |
| 510k Number | K913102 |
| Device Name: | PETERS CARDIONYL(TM) SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach, CA 92660 |
| Contact | Lee Hand |
| Correspondent | Lee Hand PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach, CA 92660 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-12 |
| Decision Date | 1992-08-03 |