The following data is part of a premarket notification filed by Analytic Technology with the FDA for Touch N' Heat, Modification.
Device ID | K921604 |
510k Number | K921604 |
Device Name: | TOUCH N' HEAT, MODIFICATION |
Classification | Unit, Electrosurgical, And Accessories, Dental |
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 | EKZ |
CFR Regulation Number | 872.4920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-27 |
Decision Date | 1992-08-24 |