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 |