The following data is part of a premarket notification filed by California Laboratories, Inc. with the FDA for Chrys(tm) Model Med-max.
| Device ID | K875338 |
| 510k Number | K875338 |
| Device Name: | CHRYS(TM) MODEL MED-MAX |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CALIFORNIA LABORATORIES, INC. 5964 LA PLACE COURT Carlsbad, CA 92008 -8861 |
| Contact | Victor C Kemp |
| Correspondent | Victor C Kemp CALIFORNIA LABORATORIES, INC. 5964 LA PLACE COURT Carlsbad, CA 92008 -8861 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-30 |
| Decision Date | 1988-04-13 |