The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Proxenon 350, Model 902xx.
| Device ID | K071218 |
| 510k Number | K071218 |
| Device Name: | PROXENON 350, MODEL 902XX |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | WELCH ALLYN, INC. 4341 STATE STREET ROAD PO BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | John E Sawyer |
| Correspondent | John E Sawyer WELCH ALLYN, INC. 4341 STATE STREET ROAD PO BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-02 |
| Decision Date | 2007-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H834902200 | K071218 | 000 |