The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Hip Sys Distal Centralizing Spacer.
Device ID | K852449 |
510k Number | K852449 |
Device Name: | HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER |
Classification | Cement Obturator |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Charles H Lawyer |
Correspondent | Charles H Lawyer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | LZN |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-10 |
Decision Date | 1985-08-12 |