The following data is part of a premarket notification filed by Prentke Romich Co. with the FDA for Control 1 Environmental Control.
Device ID | K902206 |
510k Number | K902206 |
Device Name: | CONTROL 1 ENVIRONMENTAL CONTROL |
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 | 1990-05-16 |
Decision Date | 1990-05-29 |