The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp(r) Continuous Anesthesia Tray.
| Device ID | K930539 |
| 510k Number | K930539 |
| Device Name: | MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Michelle Demers |
| Correspondent | Michelle Demers MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-02 |
| Decision Date | 1993-08-27 |