CHROMOSCAN SCANNING SYSTEM

Powered Laser Surgical Instrument

MEHL/BIOPHILE INTL., INC.

The following data is part of a premarket notification filed by Mehl/biophile Intl., Inc. with the FDA for Chromoscan Scanning System.

Pre-market Notification Details

Device IDK980753
510k NumberK980753
Device Name:CHROMOSCAN SCANNING SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant MEHL/BIOPHILE INTL., INC. 48 MT. OLIVE RD. Budd Lake,  NJ  07828
ContactThomas Blake R.ph
CorrespondentThomas Blake R.ph
MEHL/BIOPHILE INTL., INC. 48 MT. OLIVE RD. Budd Lake,  NJ  07828
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-18
Decision Date1998-06-29
Summary:summary

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