AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED

Laryngoscope, Rigid

EASTMED ENTERPRISES INC.

The following data is part of a premarket notification filed by Eastmed Enterprises Inc. with the FDA for Amer Profile Miller Laryngoscope Blades, Modified.

Pre-market Notification Details

Device IDK914741
510k NumberK914741
Device Name:AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED
ClassificationLaryngoscope, Rigid
Applicant EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton,  NJ  08053
ContactRathin Putatunda
CorrespondentRathin Putatunda
EASTMED ENTERPRISES INC. 5 PEMBURY COURT Marlton,  NJ  08053
Product CodeCCW  
CFR Regulation Number868.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-18
Decision Date1992-02-03

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