Decision Date1992-07-27
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
HEMO-BAND is the device name listed in this FDA 510(k) record. The listed applicant is Innovations IN Access, Inc.. It received FDA 510(k) clearance on 1992-07-27 under 510(k) number K920614. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HEMO-BAND?
HEMO-BAND is a medical device that received FDA 510(k) clearance on 1992-07-27. The listed applicant is Innovations IN Access, Inc.. The 510(k) number is K920614.
When did HEMO-BAND receive FDA 510(k) clearance?
HEMO-BAND received FDA 510(k) clearance on 1992-07-27, under 510(k) number K920614.
Who is the listed applicant for HEMO-BAND?
The FDA 510(k) record lists Innovations IN Access, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HEMO-BAND?
The FDA product code for HEMO-BAND is KOC.
Related Devices (Code: KOC)
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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.