The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Ms Amplatz Extra Stiff Guide Wire.
| Device ID | K942382 |
| 510k Number | K942382 |
| Device Name: | MS AMPLATZ EXTRA STIFF GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Stephen B Anderson |
| Correspondent | Stephen B Anderson MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-19 |
| Decision Date | 1994-08-22 |