The following data is part of a premarket notification filed by Prentke Romich Co. with the FDA for Touch Talker.
Device ID | K914259 |
510k Number | K914259 |
Device Name: | TOUCH TALKER |
Classification | System, Communication, Powered |
Applicant | PRENTKE ROMICH CO. 1022 HEYL RD. Wooster, OH 44691 |
Contact | Michael L Molter |
Correspondent | Michael L Molter PRENTKE ROMICH CO. 1022 HEYL RD. Wooster, OH 44691 |
Product Code | ILQ |
CFR Regulation Number | 890.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-23 |
Decision Date | 1992-02-27 |