The following data is part of a premarket notification filed by Gulf Medical Fiberoptics with the FDA for Surgical Headlight.
| Device ID | K061690 |
| 510k Number | K061690 |
| Device Name: | SURGICAL HEADLIGHT |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | GULF MEDICAL FIBEROPTICS 148 DUNBAR AVE., UNIT B Oldsmar, FL 34677 |
| Contact | Marcelino Afanador |
| Correspondent | Marcelino Afanador GULF MEDICAL FIBEROPTICS 148 DUNBAR AVE., UNIT B Oldsmar, FL 34677 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-15 |
| Decision Date | 2006-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857580006386 | K061690 | 000 |
| 00857580006379 | K061690 | 000 |
| 00857580006737 | K061690 | 000 |
| B382SD3120H0 | K061690 | 000 |
| B382SD3115H0 | K061690 | 000 |
| B382SD31000 | K061690 | 000 |
| B382SD32000 | K061690 | 000 |