The following data is part of a premarket notification filed by Lucas & Rhea Mfg. with the FDA for Telemetry Power Pack Model 2.
Device ID | K891927 |
510k Number | K891927 |
Device Name: | TELEMETRY POWER PACK MODEL 2 |
Classification | Box, Battery, Pocket |
Applicant | LUCAS & RHEA MFG. ROUTE 1, BOX 12A LAVINIA, TN 38348 |
Contact | VIRGINIA RHEA |
Correspondent | VIRGINIA RHEA LUCAS & RHEA MFG. ROUTE 1, BOX 12A LAVINIA, TN 38348 |
Product Code | FCP |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-28 |
Decision Date | 1990-04-26 |