CAMELBACK HANDLE-K841969-LABELING

Orthopedic Manual Surgical Instrument

STAINLESS MFG., INC.

The following data is part of a premarket notification filed by Stainless Mfg., Inc. with the FDA for Camelback Handle-k841969-labeling.

Pre-market Notification Details

Device IDK841970
510k NumberK841970
Device Name:CAMELBACK HANDLE-K841969-LABELING
ClassificationOrthopedic Manual Surgical Instrument
Applicant STAINLESS MFG., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLXH  
CFR Regulation Number888.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-14
Decision Date1984-06-19

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