The following data is part of a premarket notification filed by Radionics Software Applications, Inc. with the FDA for Gill-thomas-cosman(gtc) Dental Tray.
| Device ID | K962155 |
| 510k Number | K962155 |
| Device Name: | GILL-THOMAS-COSMAN(GTC) DENTAL TRAY |
| Classification | Accelerator, Linear, Medical |
| Applicant | RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington, MA 01803 -0658 |
| Contact | Amy Laforte, Ph.d. |
| Correspondent | Amy Laforte, Ph.d. RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington, MA 01803 -0658 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-04 |
| Decision Date | 1996-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M433OP1 | K962155 | 000 |
| M433GTCDIMU1 | K962155 | 000 |
| M433GTCDPL1 | K962155 | 000 |
| M433GTCDMP1 | K962155 | 000 |
| M433GTCDPM10D1 | K962155 | 000 |
| M433GTCDPM10U1 | K962155 | 000 |
| M433GTCDPS1 | K962155 | 000 |
| M433GTCDPS10D1 | K962155 | 000 |
| M433GTCDPS10U1 | K962155 | 000 |
| M433GTCDTSL1 | K962155 | 000 |
| M433GTCDTSM1 | K962155 | 000 |
| M433GTCDTSS1 | K962155 | 000 |
| M433GTCOCP1 | K962155 | 000 |
| M433GTCSVS1 | K962155 | 000 |
| M433GTCDDU1 | K962155 | 000 |