The following data is part of a premarket notification filed by Cornelia Damsky, Inc. with the FDA for Performer 30 Hps.
| Device ID | K001322 |
| 510k Number | K001322 |
| Device Name: | PERFORMER 30 HPS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CORNELIA DAMSKY, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
| Contact | Cornelia Damsky |
| Correspondent | Cornelia Damsky CORNELIA DAMSKY, INC. 56 WESTCOTT RD. Stamford, CT 06902 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-26 |
| Decision Date | 2000-06-30 |