The following data is part of a premarket notification filed by Prentke Romich Co. with the FDA for Liberator.
Device ID | K925387 |
510k Number | K925387 |
Device Name: | LIBERATOR |
Classification | System, Communication, Powered |
Applicant | PRENTKE ROMICH CO. 1022 HEYL RD. Wooster, OH 44691 |
Contact | Michael Molter |
Correspondent | Michael 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 | 1992-10-26 |
Decision Date | 1993-03-29 |