The following data is part of a premarket notification filed by Medpacific Corp. with the FDA for Heater Probe-access For Medpacific Ld5000 Laser -.
| Device ID | K854500 |
| 510k Number | K854500 |
| Device Name: | HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER - |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | MEDPACIFIC CORP. 6701 SIXTH AVENUE SOUTH Seattle, WA 98108 |
| Contact | Thomas W Burnett |
| Correspondent | Thomas W Burnett MEDPACIFIC CORP. 6701 SIXTH AVENUE SOUTH Seattle, WA 98108 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1986-02-26 |