The following data is part of a premarket notification filed by Burton Medical Products Corp. with the FDA for Outpatient Iii Minor Surgery Light.
| Device ID | K042395 |
| 510k Number | K042395 |
| Device Name: | OUTPATIENT III MINOR SURGERY LIGHT |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311 |
| Contact | Asle Asmul |
| Correspondent | Asle Asmul BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-02 |
| Decision Date | 2004-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858480006261 | K042395 | 000 |
| 00858480006018 | K042395 | 000 |
| 00858480006025 | K042395 | 000 |
| 00858480006032 | K042395 | 000 |
| 00858480006049 | K042395 | 000 |
| 00858480006056 | K042395 | 000 |
| 00858480006223 | K042395 | 000 |
| 00858480006230 | K042395 | 000 |
| 00858480006247 | K042395 | 000 |
| 00858480006254 | K042395 | 000 |
| 00858480006001 | K042395 | 000 |