The following data is part of a premarket notification filed by Pfizer Medical Systems, Inc. with the FDA for Pfizer/as&e 0450 Localizer.
| Device ID | K800501 |
| 510k Number | K800501 |
| Device Name: | PFIZER/AS&E 0450 LOCALIZER |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | PFIZER MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-04 |
| Decision Date | 1980-04-10 |