The following data is part of a premarket notification filed by Perkins Mfg. Co. with the FDA for Philips Rt250 Collimator (pk8050).
Device ID | K885126 |
510k Number | K885126 |
Device Name: | PHILIPS RT250 COLLIMATOR (PK8050) |
Classification | Device, Beam Limiting, X-ray, Therapeutic |
Applicant | PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Contact | James C Furse |
Correspondent | James C Furse PERKINS MFG. CO. 1510 NORTH WASHINGTON AVE. Dallas, TX 75204 |
Product Code | KQA |
CFR Regulation Number | 892.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-12 |
Decision Date | 1989-06-01 |