The following data is part of a premarket notification filed by Bright Medical Instruments with the FDA for The Bright Medical Dilation Retractor System.
| Device ID | K992898 |
| 510k Number | K992898 |
| Device Name: | THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | BRIGHT MEDICAL INSTRUMENTS 799 N.E. 71ST ST. Boca Raton, FL 33487 |
| Contact | Robert E Simonson |
| Correspondent | Robert E Simonson BRIGHT MEDICAL INSTRUMENTS 799 N.E. 71ST ST. Boca Raton, FL 33487 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-27 |
| Decision Date | 1999-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034221106 | K992898 | 000 |
| 10705034220314 | K992898 | 000 |
| 10705034220321 | K992898 | 000 |
| 10705034220338 | K992898 | 000 |
| 10705034220345 | K992898 | 000 |
| 10705034220352 | K992898 | 000 |
| 10705034221014 | K992898 | 000 |
| 10705034221021 | K992898 | 000 |
| 10705034221038 | K992898 | 000 |
| 10705034221045 | K992898 | 000 |
| 10705034221052 | K992898 | 000 |
| 10705034221069 | K992898 | 000 |
| 10705034221076 | K992898 | 000 |
| 10705034221083 | K992898 | 000 |
| 10705034221090 | K992898 | 000 |
| 10705034220307 | K992898 | 000 |