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 |