SYRINGE, DISPOSABLE

Syringe, Piston

ORTHOPEDIC EQUIPMENT CO., INC.

The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Syringe, Disposable.

Pre-market Notification Details

Device IDK771888
510k NumberK771888
Device Name:SYRINGE, DISPOSABLE
ClassificationSyringe, Piston
Applicant ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-10-05
Decision Date1977-10-21

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