BORES* ADJUSTABLE BLADE HOLDER

Handle, Scalpel

SANTA BARBARA MEDCO, INC.

The following data is part of a premarket notification filed by Santa Barbara Medco, Inc. with the FDA for Bores* Adjustable Blade Holder.

Pre-market Notification Details

Device IDK812070
510k NumberK812070
Device Name:BORES* ADJUSTABLE BLADE HOLDER
ClassificationHandle, Scalpel
Applicant SANTA BARBARA MEDCO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGDZ  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-21
Decision Date1981-08-18

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