SIGMA Sterilization Pouch and Roll
K-Number: K180661 · 2018-06-05
ApplicantSigma Medical Supplies Corp.
Decision Date2018-06-05
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SIGMA Sterilization Pouch and Roll is a medical device manufactured by Sigma Medical Supplies Corp.. It received FDA 510(k) clearance on 2018-06-05 under approval number K180661. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SIGMA Sterilization Pouch and Roll?
SIGMA Sterilization Pouch and Roll is a medical device that received FDA 510(k) clearance on 2018-06-05. It is manufactured by Sigma Medical Supplies Corp.. The 510(k) number is K180661.
When was SIGMA Sterilization Pouch and Roll approved by the FDA?
SIGMA Sterilization Pouch and Roll received FDA 510(k) clearance on 2018-06-05, under approval number K180661.
What company makes SIGMA Sterilization Pouch and Roll?
SIGMA Sterilization Pouch and Roll is manufactured by Sigma Medical Supplies Corp..
What is the FDA product code for SIGMA Sterilization Pouch and Roll?
The FDA product code for SIGMA Sterilization Pouch and Roll is FRG.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.