The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt Accessory Depthalon Electrode Anchor Bolt (2103-23-xx).
| Device ID | K970418 |
| 510k Number | K970418 |
| Device Name: | PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) |
| Classification | Electrode, Depth |
| Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Contact | Edward F Valdez |
| Correspondent | Edward F Valdez PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-04 |
| Decision Date | 1997-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650551144052 | K970418 | 000 |