RUBY & SAPPHIRE BLADE HOLDER

Knife, Ophthalmic

KEELER INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Ruby & Sapphire Blade Holder.

Pre-market Notification Details

Device IDK861748
510k NumberK861748
Device Name:RUBY & SAPPHIRE BLADE HOLDER
ClassificationKnife, Ophthalmic
Applicant KEELER INSTRUMENTS, INC. 456 PKWY. Broomall,  PA  19008
ContactVan Arsdale
CorrespondentVan Arsdale
KEELER INSTRUMENTS, INC. 456 PKWY. Broomall,  PA  19008
Product CodeHNN  
CFR Regulation Number886.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-06
Decision Date1986-06-02

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