The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Monotube Tube-to-tube Clamp.
| Device ID | K954667 |
| 510k Number | K954667 |
| Device Name: | MONOTUBE TUBE-TO-TUBE CLAMP |
| Classification | Component, Traction, Invasive |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | John Dichiara |
| Correspondent | John Dichiara HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1996-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327095029 | K954667 | 000 |
| 07613327095012 | K954667 | 000 |
| 07613327095005 | K954667 | 000 |
| 07613327094992 | K954667 | 000 |
| 07613327094985 | K954667 | 000 |