The following data is part of a premarket notification filed by Analytic Technology with the FDA for Touch 'n Heat Model 5002, Modification.
| Device ID | K915243 |
| 510k Number | K915243 |
| Device Name: | TOUCH 'N HEAT MODEL 5002, MODIFICATION |
| Classification | Gutta-percha |
| Applicant | ANALYTIC TECHNOLOGY 15233 NORTHEAST 90TH ST. Redmond, WA 98052 |
| Contact | Johan Masreliez |
| Correspondent | Johan Masreliez ANALYTIC TECHNOLOGY 15233 NORTHEAST 90TH ST. Redmond, WA 98052 |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-31 |
| Decision Date | 1992-01-21 |