The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica(r) Acetabular Comp Pack/manuf Meth Change.
| Device ID | K934060 |
| 510k Number | K934060 |
| Device Name: | HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JWH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-19 |
| Decision Date | 1995-08-18 |