The following data is part of a premarket notification filed by Bregma International Trading Company Ltd. with the FDA for Stainless Steel Soft Suture Wire.
Device ID | K990355 |
510k Number | K990355 |
Device Name: | STAINLESS STEEL SOFT SUTURE WIRE |
Classification | Wire, Surgical |
Applicant | BREGMA INTERNATIONAL TRADING COMPANY LTD. 214-111 RESEARCH DR. Saskatoon, Saskatchewan, CA S7n 3r2 |
Contact | Assem Hedayat |
Correspondent | Assem Hedayat BREGMA INTERNATIONAL TRADING COMPANY LTD. 214-111 RESEARCH DR. Saskatoon, Saskatchewan, CA S7n 3r2 |
Product Code | LRN |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-05 |
Decision Date | 1999-07-08 |