FIBER OPTICS SIGMOIDOSCOPE

Endoscope, Ac-powered And Accessories

PROPPER MFG. CO., INC.

The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Fiber Optics Sigmoidoscope.

Pre-market Notification Details

Device IDK771919
510k NumberK771919
Device Name:FIBER OPTICS SIGMOIDOSCOPE
ClassificationEndoscope, Ac-powered And Accessories
Applicant PROPPER MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGCP  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-10-12
Decision Date1977-10-20

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