The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Gill-thomas-cosman (gtc) Relocatable Head Holder System With Depth Confirmation Helmet(dh-1).
| Device ID | K934523 |
| 510k Number | K934523 |
| Device Name: | GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1) |
| Classification | Accelerator, Linear, Medical |
| Applicant | RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-17 |
| Decision Date | 1995-02-08 |