Decision Date2001-10-05
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
W & H ASSISTINA is the device name listed in this FDA 510(k) record. The listed applicant is A-Dec, Inc.. It received FDA 510(k) clearance on 2001-10-05 under 510(k) number K010127. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the W & H ASSISTINA?
W & H ASSISTINA is a medical device that received FDA 510(k) clearance on 2001-10-05. The listed applicant is A-Dec, Inc.. The 510(k) number is K010127.
When did W & H ASSISTINA receive FDA 510(k) clearance?
W & H ASSISTINA received FDA 510(k) clearance on 2001-10-05, under 510(k) number K010127.
Who is the listed applicant for W & H ASSISTINA?
The FDA 510(k) record lists A-Dec, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for W & H ASSISTINA?
The FDA product code for W & H ASSISTINA is EFB.
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Other records listing A-Dec, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.