PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER

Light, Surgical, Accessories

AMERICAN MEDICAL MFG., INC.

The following data is part of a premarket notification filed by American Medical Mfg., Inc. with the FDA for Plastic Disposable Surgical Light Handle Cover.

Pre-market Notification Details

Device IDK915068
510k NumberK915068
Device Name:PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER
ClassificationLight, Surgical, Accessories
Applicant AMERICAN MEDICAL MFG., INC. 22231 MULHOLLAND HWY. Calabasas,  CA  91302
ContactMike Hoftman
CorrespondentMike Hoftman
AMERICAN MEDICAL MFG., INC. 22231 MULHOLLAND HWY. Calabasas,  CA  91302
Product CodeFTA  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-08
Decision Date1992-02-06

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