The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Soft Tissue Anchoring Set Kit.
Device ID | K874439 |
510k Number | K874439 |
Device Name: | SOFT TISSUE ANCHORING SET KIT |
Classification | General Surgery Tray |
Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Contact | Lori Colvin |
Correspondent | Lori Colvin CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-28 |
Decision Date | 1987-11-20 |