The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Radiopaque Ruler.
Device ID | K902606 |
510k Number | K902606 |
Device Name: | RADIOPAQUE RULER |
Classification | System, X-ray, Stationary |
Applicant | PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Contact | James E Williams |
Correspondent | James E Williams PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-12 |
Decision Date | 1990-09-27 |