Decision Date1992-07-24
Product CodeMMK
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
HYPO-GARD is the device name listed in this FDA 510(k) record. The listed applicant is Epi Medical Products, Inc.. It received FDA 510(k) clearance on 1992-07-24 under 510(k) number K921913. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HYPO-GARD?
HYPO-GARD is a medical device that received FDA 510(k) clearance on 1992-07-24. The listed applicant is Epi Medical Products, Inc.. The 510(k) number is K921913.
When did HYPO-GARD receive FDA 510(k) clearance?
HYPO-GARD received FDA 510(k) clearance on 1992-07-24, under 510(k) number K921913.
Who is the listed applicant for HYPO-GARD?
The FDA 510(k) record lists Epi Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HYPO-GARD?
The FDA product code for HYPO-GARD is MMK.
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Official Source
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