The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Hip Plate Removal Instrument.
Device ID | K780300 |
510k Number | K780300 |
Device Name: | HIP PLATE REMOVAL INSTRUMENT |
Classification | Extractor |
Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HWB |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-02-22 |
Decision Date | 1978-02-28 |