The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Dall-miles Suture/beaded Cable.
| Device ID | K953818 |
| 510k Number | K953818 |
| Device Name: | DALL-MILES SUTURE/BEADED CABLE |
| Classification | Cerclage, Fixation |
| 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 | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-15 |
| Decision Date | 1995-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327036466 | K953818 | 000 |
| 07613327036435 | K953818 | 000 |