The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Klsa Martin Hand Distractor.
| Device ID | K042066 |
| 510k Number | K042066 |
| Device Name: | KLSA MARTIN HAND DISTRACTOR |
| Classification | Component, Traction, Invasive |
| Applicant | KLS-MARTIN L.P. 1239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Jennifer Damato KLS-MARTIN L.P. 1239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-02 |
| Decision Date | 2004-08-25 |
| Summary: | summary |