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FDA 510(k)

TOPICAL COOLING DEV. TCD. #27-999

K-Number: K800717 · 1980-04-16

ApplicantCobe Laboratories, Inc.
Decision Date1980-04-16
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TOPICAL COOLING DEV. TCD. #27-999 is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1980-04-16 under 510(k) number K800717. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPICAL COOLING DEV. TCD. #27-999?

TOPICAL COOLING DEV. TCD. #27-999 is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K800717.

When did TOPICAL COOLING DEV. TCD. #27-999 receive FDA 510(k) clearance?

TOPICAL COOLING DEV. TCD. #27-999 received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800717.

Who is the listed applicant for TOPICAL COOLING DEV. TCD. #27-999?

The FDA 510(k) record lists Cobe Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOPICAL COOLING DEV. TCD. #27-999?

The FDA product code for TOPICAL COOLING DEV. TCD. #27-999 is DTR.

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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.

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