The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Optical Catheter Introducer Sets, Modification.
| Device ID | K914315 |
| 510k Number | K914315 |
| Device Name: | OPTICAL CATHETER INTRODUCER SETS, MODIFICATION |
| Classification | Tape And Bandage, Adhesive |
| Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Contact | Jo Brehm |
| Correspondent | Jo Brehm MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-05 |
| Decision Date | 1992-03-04 |