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FDA 510(k)

MEDICOOL PROTECTALL

K-Number: K934703 · 1994-01-26

ApplicantAvc Regulatory Compliance/Technical Services
Decision Date1994-01-26
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDICOOL PROTECTALL is the device name listed in this FDA 510(k) record. The listed applicant is Avc Regulatory Compliance/Technical Services. It received FDA 510(k) clearance on 1994-01-26 under 510(k) number K934703. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICOOL PROTECTALL?

MEDICOOL PROTECTALL is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Avc Regulatory Compliance/Technical Services. The 510(k) number is K934703.

When did MEDICOOL PROTECTALL receive FDA 510(k) clearance?

MEDICOOL PROTECTALL received FDA 510(k) clearance on 1994-01-26, under 510(k) number K934703.

Who is the listed applicant for MEDICOOL PROTECTALL?

The FDA 510(k) record lists Avc Regulatory Compliance/Technical Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDICOOL PROTECTALL?

The FDA product code for MEDICOOL PROTECTALL is LDQ.

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Related Devices (Code: LDQ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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