The following data is part of a premarket notification filed by Mehl/biophile Intl., Inc. with the FDA for Chromoscan Scanning System.
| Device ID | K980753 |
| 510k Number | K980753 |
| Device Name: | CHROMOSCAN SCANNING SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEHL/BIOPHILE INTL., INC. 48 MT. OLIVE RD. Budd Lake, NJ 07828 |
| Contact | Thomas Blake R.ph |
| Correspondent | Thomas Blake R.ph MEHL/BIOPHILE INTL., INC. 48 MT. OLIVE RD. Budd Lake, NJ 07828 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-18 |
| Decision Date | 1998-06-29 |
| Summary: | summary |