The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Catheter, Silicone Coated.
Device ID | K772218 |
510k Number | K772218 |
Device Name: | CATHETER, SILICONE COATED |
Classification | Catheter, Retention Type, Balloon |
Applicant | CONCORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EZL |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-02 |
Decision Date | 1977-12-13 |