The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Nomos Slit Collimator (beak).
Device ID | K974310 |
510k Number | K974310 |
Device Name: | NOMOS SLIT COLLIMATOR (BEAK) |
Classification | Accelerator, Linear, Medical |
Applicant | NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
Contact | Marvin L Sussman |
Correspondent | Marvin L Sussman NOMOS CORP. 2591 WEXFORD BAYNE RD. SUITE 400 Sewickley, PA 15143 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-17 |
Decision Date | 1998-02-06 |
Summary: | summary |