The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Erch Arch Bar, Model 38-690-00.
| Device ID | K061271 |
| 510k Number | K061271 |
| Device Name: | ERCH ARCH BAR, MODEL 38-690-00 |
| Classification | Lock, Wire, And Ligature, Intraoral |
| Applicant | KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Jennifer Damato KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Product Code | DYX |
| CFR Regulation Number | 872.4600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-05 |
| Decision Date | 2006-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H834PM6700 | K061271 | 000 |
| M274P6700 | K061271 | 000 |