The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Switching Stick.
Device ID | K873009 |
510k Number | K873009 |
Device Name: | CONCEPT SWITCHING STICK |
Classification | Accessories, Catheter |
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 | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-04 |
Decision Date | 1987-08-17 |