The following data is part of a premarket notification filed by Pfizer Laser Systems with the FDA for The S.a.f.e. System.
| Device ID | K880890 |
| 510k Number | K880890 |
| Device Name: | THE S.A.F.E. SYSTEM |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718 |
| Contact | Linda Dibenedetto |
| Correspondent | Linda Dibenedetto PFIZER LASER SYSTEMS 3 MORGAN Irvine, CA 92718 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-02 |
| Decision Date | 1988-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850043007067 | K880890 | 000 |