The following data is part of a premarket notification filed by Northwest Medical Physics Center with the FDA for Shoulder Retractor.
Device ID | K944613 |
510k Number | K944613 |
Device Name: | SHOULDER RETRACTOR |
Classification | System, X-ray, Stationary |
Applicant | NORTHWEST MEDICAL PHYSICS CENTER 21031 67TH AVE. W. Lynnwood, WA 98036 |
Contact | Andrew Jones |
Correspondent | Andrew Jones NORTHWEST MEDICAL PHYSICS CENTER 21031 67TH AVE. W. Lynnwood, WA 98036 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-20 |
Decision Date | 1995-01-18 |