The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for C.c.f. Femoral Debridement Probe.
Device ID | K790996 |
510k Number | K790996 |
Device Name: | C.C.F. FEMORAL DEBRIDEMENT PROBE |
Classification | Reamer |
Applicant | DEPUY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HTO |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-29 |
Decision Date | 1979-06-27 |