The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Solid State Lamp [led] Headlight.
| Device ID | K031549 |
| 510k Number | K031549 |
| Device Name: | SOLID STATE LAMP [LED] HEADLIGHT |
| Classification | Light, Headband, Surgical |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | David Klementowski |
| Correspondent | David Klementowski WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | FSR |
| CFR Regulation Number | 886.4335 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-16 |
| Decision Date | 2003-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094073300 | K031549 | 000 |
| 00732094002591 | K031549 | 000 |