Decision Date1993-03-16
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
PALA-NATE is the device name listed in this FDA 510(k) record. The listed applicant is Gesco Intl., Inc.. It received FDA 510(k) clearance on 1993-03-16 under 510(k) number K923591. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PALA-NATE?
PALA-NATE is a medical device that received FDA 510(k) clearance on 1993-03-16. The listed applicant is Gesco Intl., Inc.. The 510(k) number is K923591.
When did PALA-NATE receive FDA 510(k) clearance?
PALA-NATE received FDA 510(k) clearance on 1993-03-16, under 510(k) number K923591.
Who is the listed applicant for PALA-NATE?
The FDA 510(k) record lists Gesco Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PALA-NATE?
The FDA product code for PALA-NATE is BTR.
Other records listing Gesco Intl., 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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Related Devices (Code: BTR)
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.